Label: BROAD SPECTRUM WATER RESISTANT SPF 50 MINERAL SUNSCREEN FACES- titanium dioxide, zinc oxide cream
- NDC Code(s): 53675-175-00
- Packager: Aruba Aloe Balm NV
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
- apply generously 15 minutes before sun exposure
- reapply
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 andd 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
- children under 6 months of age: Ask a doctor
- Other Information
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Inactive ingredients
Water (Aqua/Eau), Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), AcetylatedHydrogenated Vegetable Glyceride, Polyglyceryl-3 Polyricinoleate, Caprylic/Capric Triglyceride, Phenoxyethanol, CaprylylGlycol, Chlorphenesin, Polyhydroxystearic Acid, Stearic Acid, Alumina, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Beheneth-25Methacrylate Copolymer, Tocopheryl (Vitamin E) Acetate, Sodium Hydroxide.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
BROAD SPECTRUM WATER RESISTANT SPF 50 MINERAL SUNSCREEN FACES
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53675-175 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 100 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) PROPANEDIOL (UNII: 5965N8W85T) ALOE VERA LEAF (UNII: ZY81Z83H0X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ACETATE ION (UNII: 569DQM74SC) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53675-175-00 59 mL in 1 TUBE; Type 0: Not a Combination Product 10/25/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/25/2017 Labeler - Aruba Aloe Balm NV (855442273) Establishment Name Address ID/FEI Business Operations Aruba Aloe Balm NV 855442273 manufacture(53675-175)
