Label: OS-01 BODY SPF 30- zinc oxide cream
- NDC Code(s): 62742-4264-1, 62742-4264-2
- Packager: Allure Labs
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 20, 2024
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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
Direction-
Apply liberally 15 minutes before sun exposure.
Reapply after 80 minutes of swimming or sweating.
immediately after towel drying, at least every 2 hours
Children under 6 months of age: Ask a doctor.
Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad-spectrum value of 15 or higher and other sun protection measures including:
Limit time in the sun. especially from 10 am to 2 pm
Wear long-sleeved shirts, pants hats and sunglasses. - OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients: Caprylic/Capric Triglyceride 40 - 65 Butyloctyl Salicylate, C13-15 Alkane, Stearalkonium Hectorite,Coconut Alkanes, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Wax, Propylene Carbonate, Quaternium-90 Bentonite, Butyrospermum Parkii Nut Extract, Decapeptide-52, Camellia Oleifera (Tea) Seed Oil, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Aloe Barbadensis Leaf Extract, Carthamus Tinctorius Seed Oil, Lactobacillus/Acerola Cherry Ferment, Coco-Caprylate/Caprate, Ceramide NP, Ceramide AP, Ceramide EOP, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Lecithin, Phytosphingosine, Cholesterol, Sodium lauroyl lactylate , Carbomer, Xanthan gum, Water, Propylene Glycol ,Triethyl Citrate, Citric Acid, Sodium Benzoate, Phenoxyethanol.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OS-01 BODY SPF 30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4264 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14 g in 100 g Inactive Ingredients Ingredient Name Strength BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) CANDELILLA WAX (UNII: WL0328HX19) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) SHEANUT (UNII: 84H6HBP32L) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) SODIUM BENZOATE (UNII: OJ245FE5EU) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) SAFFLOWER OIL (UNII: 65UEH262IS) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) ISOSTEARIC ACID (UNII: X33R8U0062) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C) CAMELLIA OIL (UNII: T1PE06G0VE) ALOE VERA LEAF (UNII: ZY81Z83H0X) MALPIGHIA EMARGINATA SEED (UNII: 1X7L93686M) CERAMIDE NP (UNII: 4370DF050B) CERAMIDE AP (UNII: F1X8L2B00J) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CHOLESTEROL (UNII: 97C5T2UQ7J) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) C13-15 ALKANE (UNII: 114P5I43UJ) COCONUT ALKANES (UNII: 1E5KJY107T) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4264-2 1 in 1 CARTON 06/20/2024 1 NDC:62742-4264-1 100 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 Drug M020 06/20/2024 Labeler - Allure Labs (926831603) Registrant - Allure LAbs (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4264)