Label: LEGEND AGE WHITENING SUNSCREEN- sunscreen cream
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Contains inactivated NDC Code(s)
NDC Code(s): 82142-001-01, 82142-001-02 - Packager: Guangzhou Fu Zhuang Biotechnology Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 23, 2021
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- WARNINGS
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INACTIVE INGREDIENT
Water, Dipropylene Glycol, Alcohol Denat, 4-Methylbenzylidene Camphor, Glyceryl Stearate, Niacinamide, Pentylene Glycol, Dicaprylyl Carbonate, PEG-100 Stearate, Cyclopentasiloxan, Ethylhexyl Triazone, Panthenol, Polymethylsilsesquioxane, Polysorbate 60, Behenyl Alcohol, Caprylyl Methicone, Triceteareth-4 Phosphate, Glycol Stearate, Pentaerythrityl Distearate, PEG-2 Stearate, Caprylyl Glycol, Glyceryl Caprylate, Silicon Dioxide, Xanthan Gum, Mica, Fragrance(Parfum), Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Isohexadecane, Dimethicone Crosspolymer, PEG-12 Dimethicone Crosspolymer, Polysorbate 80, Disodium EDTA, Sorbitan Oleate, Triethoxycaprylylsilane, Tocopherol, Camellia Japonica Seed Oil, Phenylethyl Resorcinol, Hydrogenated Polydecene, Angelica Gigas Root Extract, Cnidium Officinale Root Extract, Paeonia Lactiflora Root Extract, Rehmannia Glutinosa Root Extract
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEGEND AGE WHITENING SUNSCREEN
sunscreen creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82142-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 4.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529) NIACINAMIDE (UNII: 25X51I8RD4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TOCOPHEROL (UNII: R0ZB2556P8) CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ALCOHOL (UNII: 3K9958V90M) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) XANTHAN GUM (UNII: TTV12P4NEE) MICA (UNII: V8A1AW0880) POLYSORBATE 60 (UNII: CAL22UVI4M) PENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB) ENZACAMENE (UNII: 8I3XWY40L9) PENTYLENE GLYCOL (UNII: 50C1307PZG) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO) GLYCOL STEARATE (UNII: 0324G66D0E) DOCOSANOL (UNII: 9G1OE216XY) WATER (UNII: 059QF0KO0R) PEG-100 STEARATE (UNII: YD01N1999R) PANTHENOL (UNII: WV9CM0O67Z) PEG-2 STEARATE (UNII: 94YQ11Y95F) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO) ANGELICA GIGAS ROOT (UNII: 32766B2FHX) CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J) PHENYLETHYL RESORCINOL (UNII: G37UFG162O) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82142-001-02 1 in 1 BOX 11/18/2021 1 NDC:82142-001-01 40 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/23/2021 Labeler - Guangzhou Fu Zhuang Biotechnology Co.,Ltd. (419815629) Establishment Name Address ID/FEI Business Operations Guangzhou Fu Zhuang Biotechnology Co.,Ltd. 419815629 manufacture(82142-001)
