Otc - Active Ingredient
Titanium Dioxide - 4.3%
Zinc Oxide - 15.0%
The following Structured Product Label (SPL) was submitted to the FDA by Coola, Llc for the product Bare Republic Spf 50 Mineral Sunscreen Vanilla Coco (NDC 79753-048). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, warnings, otc - keep out of reach of children, directions, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Titanium Dioxide - 4.3%
Zinc Oxide - 15.0%
Sunscreen
• Helps prevent sunburn
• If used as directed with other sun protection measures (see
Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
• Shake well. Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. • When properly used, mineral sunscreens will leave a whitish tint when first applied.
• Reapply: • after 80 minutes of swimming or sweating • immediately afrer 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 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-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor
Water, Helianthus Anuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, lsocetyl Stearoyl Stearate, Methyl Dihydrobietate, Polysorbate 20, Cetearyl Alcohol, Bentonite, Propanediol, Aloe Barbadensis Leaf Juice, Vitis Vinifera (Grape) Seed Oil, Rubus ldaeus (Raspberry) Seed Oil, Daucus Carota Saliva (Carrot) Seed Oil, Bisabolol, Coco-Glucoside, Microstalline Cellulose, Cellulose Gum, Sodium Gluconate, Sodium Stearoyl Glutamate, Caprylhydroxamic Acid, Polyester-8, Alumina, Silica, Tocopherol, Citric Acid, Caprylic/Capric Triglyceride, Alcohol, Vanillin, Gamma-Nonalactone, Allyl Heptoate, Gamma Octalactone, Heliotropine, Raspberry Ketone, Triethyl Citrate
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