Label: TROPICAL TOPICAL MATTE SPF 30- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4157-1, 62742-4157-2 - Packager: Allure Labs Inc
- 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 December 12, 2017
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Other Ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl, Dimethicone, Sorbitan Stearate, Cetyl Alcohol, Teprenone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylic/Capric Triglyceride, Imperata Cylendrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Lecithin, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/ Oleate, Citric Acid, Polyacrylamide, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerine, Hexylene Glycol, Xanthan Gum, C13-14 Isoparaffin, Laureth-7, PEG-8, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopherol, Asccorbyl Palmitate, Ascorbc Acid, Fragrance, Disodium EDTA.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TROPICAL TOPICAL MATTE SPF 30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4157 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 186 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PEG-100 STEARATE (UNII: YD01N1999R) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) TEPRENONE (UNII: S8S8451A4O) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX) PHOENIX DACTYLIFERA WHOLE (UNII: 8QI9RWU9M1) POLYGONUM AVICULARE WHOLE (UNII: M990N03611) SODIUM LACTATE (UNII: TU7HW0W0QT) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) TOCOPHEROL (UNII: R0ZB2556P8) CITRIC ACID ACETATE (UNII: DSO12WL7AU) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) XANTHAN GUM (UNII: TTV12P4NEE) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) PEG-8 DIMETHICONE (UNII: GIA7T764OD) CARBOMER 934 (UNII: Z135WT9208) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) ASCORBYL PALMITATE (UNII: QN83US2B0N) ASCORBIC ACID (UNII: PQ6CK8PD0R) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4157-2 1 in 1 CARTON 12/12/2017 1 NDC:62742-4157-1 57 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 12/12/2017 Labeler - Allure Labs Inc (926831603)
