Label: HYDRATING MINERAL SUNSCREEN BS SPF30- zinc oxide cream
- NDC Code(s): 62742-4260-1, 62742-4260-2
- Packager: Allure Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 15, 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
Directions • apply liberally 15 minutes before sun exposure •reapply at least every 2 hours • children under 6 months: Ask a doctor • 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 sun-glasses.
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, Glyceryl Caprylate, Coco-Glucoside, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Honey, Avena sativa (Oat) Kernel Flour, Sodium Phytate, Caprylyl/Capryl Glucoside, Xanthan Gum, Dipotassium Glycyrrhizate, Sclerotium Gum, Cetearyl Glucoside, Butyrospermum Parkii (Shea) Butter, Tocopherol, Coco-Caprylate/Caprate, Caprylhydroxamic acid, Sucrose, Spirulina Maxima Extract, Phaeodactylum Tricornutum Extract, Oryza Sativa Starch, Bisabolol,Lecithin, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Beta-Sitosterol, Squalene, Glucose, C8 Alcohol, C10 Alcohol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRATING MINERAL SUNSCREEN BS SPF30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4260 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 21 g in 100 g Inactive Ingredients Ingredient Name Strength HONEY (UNII: Y9H1V576FH) PHYTATE SODIUM (UNII: 88496G1ERL) XANTHAN GUM (UNII: TTV12P4NEE) ISOSTEARIC ACID (UNII: X33R8U0062) SUNFLOWER OIL (UNII: 3W1JG795YI) SQUALENE (UNII: 7QWM220FJH) .BETA.-SITOSTEROL (UNII: S347WMO6M4) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) STARCH, RICE (UNII: 4DGK8B7I3S) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) SPIRULINA MAXIMA (UNII: 9K7IG15M0Q) PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV) DECYL ALCOHOL (UNII: 89V4LX791F) COCO GLUCOSIDE (UNII: ICS790225B) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARGAN OIL (UNII: 4V59G5UW9X) OATMEAL (UNII: 8PI54V663Y) SHEA BUTTER (UNII: K49155WL9Y) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCONUT ALKANES (UNII: 1E5KJY107T) BETASIZOFIRAN (UNII: 2X51AD1X3T) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TOCOPHEROL (UNII: R0ZB2556P8) SUCROSE (UNII: C151H8M554) LEVOMENOL (UNII: 24WE03BX2T) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4260-2 1 in 1 CARTON 04/15/2024 1 NDC:62742-4260-1 48 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 04/15/2024 Labeler - Allure Labs (926831603) Registrant - Allure Labs (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4260)