Label: GROOMWELL WEIGHTLESS WITH MINERAL BROAD SPECTRUM SPF 15 SUNSCREEN- zinc oxide cream
- NDC Code(s): 42508-827-23
- Packager: Arbonne International, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 12, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
For sunscreen use:
- apply liberally and evenly 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- children under 6 months of age: Ask a doctor
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Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.–2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
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Inactive ingredients
water, C12-15 alkyl benzoate, glycerin, isononyl isononanoate, saccharide isomerate, steareth-21, squalane, ammonium acryloyldimethyltaurate/VP copolymer, caprylic/capric triglyceride, dimethicone, steareth-2, aloe barbadensis leaf juice, hydrolyzed ceratonia siliqua seed extract, laminaria digitata extract, chamomilla recutita (matricaria) flower extract, sophora japonica flower extract, tripleurospermum maritimum extract, malachite extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dehydroxanthan gum, tetrahexyldecyl ascorbate, dipotassium glycyrrhizate, menthol, adenosine, sodium hyaluronate, polyglyceryl-3 laurate, sorbitan oleate, sorbitan isostearate, myristic acid, palmitic acid, stearic acid, triethoxycaprylylsilane, polysorbate 60, propanediol, trisodium ethylenediamine disuccinate, sodium citrate, citric acid, caprylhydroxamic acid, caprylyl glycol, phenoxyethanol, chlorphenesin, sodium benzoate, potassium sorbate, sorbic acid.
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 g Jar Carton
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INGREDIENTS AND APPEARANCE
GROOMWELL WEIGHTLESS WITH MINERAL BROAD SPECTRUM SPF 15 SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42508-827 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 49.5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) SACCHARIDE ISOMERATE (UNII: W8K377W98I) STEARETH-21 (UNII: 53J3F32P58) SQUALANE (UNII: GW89575KF9) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) STEARETH-2 (UNII: V56DFE46J5) ALOE VERA LEAF (UNII: ZY81Z83H0X) LAMINARIA DIGITATA (UNII: 15E7C67EE8) CHAMOMILE (UNII: FGL3685T2X) STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) ADENOSINE (UNII: K72T3FS567) HYALURONATE SODIUM (UNII: YSE9PPT4TH) POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) MYRISTIC ACID (UNII: 0I3V7S25AW) PALMITIC ACID (UNII: 2V16EO95H1) STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPANEDIOL (UNII: 5965N8W85T) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42508-827-23 1 in 1 CARTON 04/27/2021 07/26/2026 1 50 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/27/2021 07/26/2026 Labeler - Arbonne International, LLC (961643454) Registrant - Levlad, LLC (076245109) Establishment Name Address ID/FEI Business Operations Levlad, LLC 076245109 manufacture(42508-827) , label(42508-827) , pack(42508-827) , analysis(42508-827)
