<?xml version="1.0" encoding="UTF-8" standalone="no"?><?xml-stylesheet href="../../stylesheet/spl.xsl" type="text/xsl"?><document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
  <id root="bb4c2923-7ed8-4e17-a8ae-e0653d166589"/>
  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>Formula 2</title>
  <effectiveTime value="20211115"/>
  <setId root="9e4caf7f-e1cc-4b24-a78b-71115390bb6a"/>
  <versionNumber value="2"/>
  <author>
    <time/>
    <assignedEntity>
      <representedOrganization>
        <id extension="053560311" root="1.3.6.1.4.1.519.1"/>
        <name>20Lighter, LLC.</name>
      </representedOrganization>
    </assignedEntity>
  </author>
  <component>
    <structuredBody>
      <component>
        <section>
          <id root="71f46607-8414-4250-b37c-18347659bba0"/>
          <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
          <title/>
          <text/>
          <effectiveTime value="20211115"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="73399-002" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Formula 2</name>
                <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Agnus Castus, Alpha lipoicum acidum, Androsterone 1 DHEA, Calcarea carbonica,Cinchona officinalis, Cynara Scolymus, Dopamine Hydrochloride, Hydrastis canadensis, Lycopodium clavatum, Oxytocin acetate, Quercetin, Sarcolacticum, Serotonin, Ignatia amara, Tiliroside, Ubiquinone, Valeriana Officinalis,</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="60"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="433OSF3U8A" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CHASTE TREE FRUIT</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="433OSF3U8A" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>CHASTE TREE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="73Y7P0K73Y" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ALPHA LIPOIC ACID</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="73Y7P0K73Y" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>.ALPHA.-LIPOIC ACID</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="C24W7J5D5R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ANDROSTERONE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="C24W7J5D5R" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>ANDROSTERONE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_C]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="2E32821G6I" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>OYSTER SHELL CALCIUM CARBONATE, CRUDE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="2E32821G6I" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>OYSTER SHELL CALCIUM CARBONATE, CRUDE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="S003A158SB" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CINCHONA OFFICINALIS BARK</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="S003A158SB" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>CINCHONA OFFICINALIS BARK</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="60"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="B71UA545DE" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CYNARA SCOLYMUS LEAF</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="B71UA545DE" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>CYNARA SCOLYMUS LEAF</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="ZW3Z11D0JV" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GOLDENSEAL</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="ZW3Z11D0JV" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>GOLDENSEAL</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="C88X29Y479" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>LYCOPODIUM CLAVATUM SPORE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="C88X29Y479" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>LYCOPODIUM CLAVATUM SPORE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="9IKM0I5T1E" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>QUERCETIN</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="9IKM0I5T1E" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>QUERCETIN</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_C]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="F9S9FFU82N" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>LACTIC ACID, L-</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="F9S9FFU82N" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>LACTIC ACID, L-</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_C]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="333DO1RDJY" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SEROTONIN</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="333DO1RDJY" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>SEROTONIN</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_C]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="1NM3M2487K" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>STRYCHNOS IGNATII SEED</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="1NM3M2487K" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>STRYCHNOS IGNATII SEED</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="15M04TXR9M" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TILIROSIDE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="15M04TXR9M" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>TILIROSIDE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="EJ27X76M46" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>UBIDECARENONE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="EJ27X76M46" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>UBIDECARENONE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="[hp_X]" value="60"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="JWF5YAW3QW" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>VALERIAN</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="JWF5YAW3QW" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>VALERIAN</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="3K9958V90M" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ALCOHOL</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>Water</name>
                  </ingredientSubstance>
                </ingredient>
                <asContent>
                  <quantity>
                    <numerator unit="mL" value="30"/>
                    <denominator unit="1" value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code code="73399-002-30" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                  </containerPackagedProduct>
                  <subjectOf>
                    <marketingAct>
                      <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                      <statusCode code="active"/>
                      <effectiveTime>
                        <low value="20200130"/>
                      </effectiveTime>
                    </marketingAct>
                  </subjectOf>
                  <subjectOf>
                    <characteristic classCode="OBS">
                      <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                      <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CE"/>
                    </characteristic>
                  </subjectOf>
                </asContent>
              </manufacturedProduct>
              <subjectOf>
                <marketingAct>
                  <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                  <statusCode code="active"/>
                  <effectiveTime>
                    <low value="20200130"/>
                  </effectiveTime>
                </marketingAct>
              </subjectOf>
              <subjectOf>
                <approval>
                  <code code="C73614" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="unapproved homeopathic"/>
                  <author>
                    <territorialAuthority>
                      <territory>
                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                      </territory>
                    </territorialAuthority>
                  </author>
                </approval>
              </subjectOf>
              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                </substanceAdministration>
              </consumedIn>
            </manufacturedProduct>
          </subject>
        </section>
      </component>
      <component>
        <section ID="L4a026040-461b-434d-818b-981f2f3244e5">
          <id root="ec236f6b-81a5-4cfd-a079-e327062751d2"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title/>
          <text>
            <paragraph>ACTIVE INGREDIENTS: Equal Amounts of: Adipose Tissue Suis 200C, Agnus Castus 60X, Alpha-lipoicum acidum 30X, 60X, 200X, Androsterone (1-DHEA) 30X, Bacopa 30C, Calcarea carbonica 30C, Chlorogenic acids 30C, Cinchona officinalis 30X, 60X, 200X, Cynara Scolymus 60X, Dopamine Hydrochloride 30C, Hydrastis canadensis 30X, 60X, Lycopodium clavatum 30X, Morgan gaertner 30C, Morgan pure 30C, Muscle Suis 200C, Oxytocin acetate 30X, 60X, 200X, Proteus bach 30C, Quercetin 30X, 60X, 200X, Rhodiola 30X, 60X, 200X, Sarcolacticum</paragraph>
            <paragraph/>
            <paragraph>* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</paragraph>
          </text>
          <effectiveTime value="20211115"/>
        </section>
      </component>
      <component>
        <section ID="L7f6be8f8-2f87-4ca5-b707-fc9f334718cb">
          <id root="d9e364b5-8c00-4146-859a-453970398a7f"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title/>
          <text>
            <paragraph>
              <content styleCode="bold">USES:</content> For the temporary relief of symptoms of food cravings, including: constant appetite, increased or insatiable hunger.*</paragraph>
          </text>
          <effectiveTime value="20211115"/>
        </section>
      </component>
      <component>
        <section ID="L964399ba-39d1-4b28-b270-f755cc7d1260">
          <id root="56e84072-44e2-4e66-915c-46afe020e82d"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title/>
          <text>
            <paragraph>▀ <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN.</content>
              <br/>
              <content styleCode="bold">▀ IF PREGNANT OR BREAST-FEEDING</content> ask your doctor before use.<br/>▀ Do not use if you have ever had an allergic reaction to this product or any of its ingredients.<br/>▀ Stop use if symptoms persist, worsen, or if new symptoms occur.</paragraph>
          </text>
          <effectiveTime value="20211115"/>
          <component>
            <section ID="L3673eaac-d331-4186-8b84-30b0395dc860">
              <id root="2afc4ee8-1f3f-4b11-b754-c4377a53638a"/>
              <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
              <title/>
              <text>
                <paragraph>▀ <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN.</content>
                </paragraph>
              </text>
              <effectiveTime value="20211115"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section ID="Lb4af033e-acf2-4574-9062-67eed36023d1">
          <id root="59225d35-5f47-4f7a-a0b2-54bdfb8a44ed"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title/>
          <text>
            <paragraph>
              <content styleCode="bold">DIRECTIONS:</content> Use as directed by a healthcare professional.</paragraph>
          </text>
          <effectiveTime value="20211115"/>
        </section>
      </component>
      <component>
        <section ID="Ld6e9453e-c260-424b-9379-b9e8de84a7a2">
          <id root="8dcd01f0-a992-4530-a7ee-eb7a06004546"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title/>
          <text>
            <paragraph>
              <content styleCode="bold">INACTIVE INGREDIENTS:</content> Ethanol 20%, Purified Water</paragraph>
          </text>
          <effectiveTime value="20211115"/>
        </section>
      </component>
      <component>
        <section ID="L6b0ff947-7f77-4753-91a7-99c61e0cc465">
          <id root="4ab17b03-68eb-4b48-9811-d2869c248d86"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title/>
          <text>
            <paragraph>
              <content styleCode="bold">Manufactured for:</content>
              <br/>20Lighter, LLC<br/>1903 S Greeley Highway, Suite 324<br/>Cheyenne, WY 82007<br/>Tel: (307) 287-1555</paragraph>
          </text>
          <effectiveTime value="20211115"/>
        </section>
      </component>
      <component>
        <section ID="Lf117b9f7-5dfe-4737-bbe8-56eb904c81a6">
          <id root="8c16a66c-106d-4237-81cc-804c7d511fa2"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title/>
          <text>
            <paragraph>73399-002-30</paragraph>
            <paragraph>20Lighter Program</paragraph>
            <paragraph>Formula #2</paragraph>
            <paragraph>Homeopathic Remedy</paragraph>
            <paragraph>1 fl oz. (30mL)</paragraph>
            <paragraph>Ethanol 20%</paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="L71b11ae3-1a49-4363-9706-4284bfeaa36c"/>
            </paragraph>
            <paragraph/>
            <paragraph>
              <renderMultiMedia referencedObject="L91121953-a75e-469d-b8c2-e207caadda12"/>
            </paragraph>
          </text>
          <effectiveTime value="20211115"/>
          <component>
            <section ID="L88151f02-9cd5-479d-9ff5-701c272fdf4f">
              <id root="96edef34-0d7b-4161-afc7-61ff60cebdfa"/>
              <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
              <title/>
              <text>
                <paragraph>
                  <content styleCode="bold">USES:</content> For the temporary relief of symptoms of food cravings, including: constant appetite, increased or insatiable hunger.*</paragraph>
              </text>
              <effectiveTime value="20211115"/>
            </section>
          </component>
          <component>
            <observationMedia ID="L71b11ae3-1a49-4363-9706-4284bfeaa36c">
              <text>1 oz bottle label</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="Formula 2 - 1 fl oz. bottle label.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="L91121953-a75e-469d-b8c2-e207caadda12">
              <text>1 oz bottle label</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="Formula 2 - 1 fl oz. bottle label..jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
  </component>
</document>