Label: TROPICAL SANDS SPF-30 BROAD SPECTRUM SUNSCREEN- titanium dioxide, zinc oxide cream
- NDC Code(s): 71221-795-06
- Packager: Elements Brands, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2023
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- DRUG FACTS
- Active Ingredients
- Uses:
- Warnings:
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Directions:
• Apply liberally 15 minutes before sun exposure • Reapply: • 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: •Limit time in the sun, especially from 10 am – 2 pm. •Wear long sleeve shirts, pants, hats and sunglasses. •For children under 6 months: consult a physician. Sun Protection Measures:
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Inactive Ingredients:
Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Seed Extract, Gluconolactone, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate,Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Japonica (Honeysuckle) Flower Extract, Mangifera Indica (Mango) Seed Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Populus Tremuloides Bark Extract, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum.
- Other Information:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
TROPICAL SANDS SPF-30 BROAD SPECTRUM SUNSCREEN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71221-795 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) WATERMELON (UNII: 231473QB6R) DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U) GLUCONOLACTONE (UNII: WQ29KQ9POT) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) AVOCADO OIL (UNII: 6VNO72PFC1) POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71221-795-06 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/21/2017 Labeler - Elements Brands, Inc. (006166707)
