Label: PREVENTION SUN SERUM SPF 30 TINTED- zinc oxide cream
- NDC Code(s): 62742-4224-1, 62742-4224-2, 62742-4224-3
- 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 January 4, 2023
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- 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
Directions • shake well before use • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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 SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients
ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/CAPRATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, TRIETHOXYCAPRYLYLSILANE, LECITHIN, IRON OXIDES (CI 77492), HYDROGENATED PALM OIL, HYDROGENATED RAPESEED OIL, COCO-CAPRYLATE/CAPRATE, HYDRATED SILICA, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, LIMONENE, CAMELLIA OLEIFERA SEED OIL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, POLYGLYCERYL-6 POLYRICINOLEATE, IRON OXIDES (CI 77491), DILINOLEIC ACID/BUTANEDIOL COPOLYMER, DISODIUM STEAROYL GLUTAMATE, AQUA/WATER/EAU, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CASTOR OIL/IPDI COPOLYMER, IRON OXIDES (CI 77499), SODIUM SULFATE, ALOE BARBADENSIS LEAF EXTRACT, CITRAL, LINALOOL, CITRIC ACID.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREVENTION SUN SERUM SPF 30 TINTED
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4224 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15.6 g in 100 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU) LIMONENE, (+)- (UNII: GFD7C86Q1W) CAMELLIA OIL (UNII: T1PE06G0VE) SAFFLOWER OIL (UNII: 65UEH262IS) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) WATER (UNII: 059QF0KO0R) PROPANEDIOL DICAPRYLATE/CAPRATE (UNII: F53961BX4F) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRAL (UNII: T7EU0O9VPP) ORANGE OIL (UNII: AKN3KSD11B) APRICOT KERNEL OIL (UNII: 54JB35T06A) SQUALANE (UNII: GW89575KF9) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FERRIC OXIDE RED (UNII: 1K09F3G675) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) CASTOR OIL (UNII: D5340Y2I9G) LINALOOL, (+/-)- (UNII: D81QY6I88E) HYDRATED SILICA (UNII: Y6O7T4G8P9) GINGER (UNII: C5529G5JPQ) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROGENATED PALM OIL (UNII: 257THB963H) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O) SODIUM SULFATE (UNII: 0YPR65R21J) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4224-1 7 g in 1 TUBE; Type 0: Not a Combination Product 01/04/2023 2 NDC:62742-4224-3 1 in 1 CARTON 01/04/2023 2 NDC:62742-4224-2 28.3 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 01/04/2023 Labeler - Allure Labs (926831603) Registrant - Allure Labs (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4224)
