Label: MINERAL SUNSCREEN SPF-30- titanium dioxide, zinc oxide liquid
- NDC Code(s): 83387-399-00
- Packager: NEWCO LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 6, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses:
- Warnings:
-
Directions:
• Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: Ask a doctor. • After 80 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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.
Reapply:Sun Protection Measures: - Other Information
-
Other Ingredients:
*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, *Carthamus Tinctorius (Safflower) Oil, Ethylhexylglycerin, *Glycerin, Glyceryl Stearate Citrate, *Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Stearic Acid, Tetrasodium Glutamate Diacetate, *Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum.
*Denotes organic ingredients
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN SPF-30
titanium dioxide, zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83387-399 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 60 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) SAFFLOWER (UNII: 4VBL71TY4Y) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) PHENOXYETHANOL (UNII: HIE492ZZ3T) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) STEARIC ACID (UNII: 4ELV7Z65AP) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) COCOA (UNII: D9108TZ9KG) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83387-399-00 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/17/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/17/2023 Labeler - NEWCO LLC (117874606)