Label: TROPICAL TOPICAL MATTE SPF30- zinc oxide cream
- NDC Code(s): 62742-4231-1, 62742-4231-2
- Packager: Allure Labs
- 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 August 23, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Direction:
Apply liberally 15 minutes before sun exposure.
Children under 6 month of age: Ask a doctor
Reapply at least every 2 hours.
Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases 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 am – 2.0 pm, Wear long – sleeved shirts, pants, hats and sunglasses.
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
INACTIVE INGREDIENT: 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 SPF30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4231 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 18.6 g in 100 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) TOCOPHEROL (UNII: R0ZB2556P8) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CETYL ALCOHOL (UNII: 936JST6JCN) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ASCORBYL PALMITATE (UNII: QN83US2B0N) PEG-100 STEARATE (UNII: YD01N1999R) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) SODIUM LACTATE (UNII: TU7HW0W0QT) LINOLEIC ACID (UNII: 9KJL21T0QJ) POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q) XANTHAN GUM (UNII: TTV12P4NEE) ASCORBIC ACID (UNII: PQ6CK8PD0R) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) CYCLOMETHICONE 6 (UNII: XHK3U310BA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) DATE (UNII: H3O7QI5HY7) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LAURETH-7 (UNII: Z95S6G8201) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) TEPRENONE (UNII: S8S8451A4O) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4231-2 1 in 1 CARTON 08/23/2023 1 NDC:62742-4231-1 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 M020 08/23/2023 Labeler - Allure Labs (926831603) Registrant - Allure Labs (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4231)