Label: TINTED BODY SCREEN MEDIUM BRONZE- titanium dioxide, zinc oxide lotion
- NDC Code(s): 75796-017-01
- Packager: Make2Give LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
- Warnings
-
Directions
• Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age : ask a doctor. • Reapply at least every 2 hours. • Use a water-resistant sunscreen if swimming or sweating. • 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. Sun Protection Measures.
- Other Information
-
Inactive ingredients
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, C-12-C-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecane, Ethyl Vanillin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Iron Oxides (Black, Red, White, Yellow), Lecithin, Mangifera Indica (Mango) Butter, Punica Granatum (Pomegranate) Extract, Saccharide lsomerate, Sodium Polyacrylate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol, Caramel Color.
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
TINTED BODY SCREEN MEDIUM BRONZE
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75796-017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 65 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) SHEA BUTTER (UNII: K49155WL9Y) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATERMELON (UNII: 231473QB6R) COCONUT OIL (UNII: Q9L0O73W7L) CARROT (UNII: L56Z1JK48B) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DODECANE (UNII: 11A386X1QH) ETHYL VANILLIN (UNII: YC9ST449YJ) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) FERRIC OXIDE RED (UNII: 1K09F3G675) MANGO (UNII: I629I3NR86) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) SACCHARIDE ISOMERATE (UNII: W8K377W98I) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) CORN (UNII: 0N8672707O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75796-017-01 88 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/01/2023 Labeler - Make2Give LLC (023910159)
