Label: BARE REPUBLIC SPF 50 MINERAL SUNSCREEN VANILLA COCO- titanium dioxide, zinc oxide spray
- NDC Code(s): 79753-048-01
- Packager: COOLA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 22, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
-
WARNINGS
- For external use only
- Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. Do not use in the presence of a flame or spark, or while smoking.
- Do not use on damaged or broken skin
- When using this product keep away from face to avoid breathing in • Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as could cause surface to become slippery. Do not apply in windy conditions. Use in a well ventilated area.
- Stop use and ask doctor if skin rash occurs
- KEEP OUT OF REACH OF CHILDREN
-
Directions
• 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
- OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BARE REPUBLIC SPF 50 MINERAL SUNSCREEN VANILLA COCO
titanium dioxide, zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-048 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.3 g in 100 mL Inactive Ingredients Ingredient Name Strength PIPERONAL (UNII: KE109YAK00) OLIVE OIL (UNII: 6UYK2W1W1E) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) WATER (UNII: 059QF0KO0R) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TOCOPHEROL (UNII: R0ZB2556P8) PROPANEDIOL (UNII: 5965N8W85T) SODIUM GLUCONATE (UNII: R6Q3791S76) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARROT SEED OIL (UNII: 595AO13F11) SUNFLOWER OIL (UNII: 3W1JG795YI) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALCOHOL (UNII: 3K9958V90M) VANILLIN (UNII: CHI530446X) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) GRAPE SEED OIL (UNII: 930MLC8XGG) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ALUMINUM OXIDE (UNII: LMI26O6933) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO GLUCOSIDE (UNII: ICS790225B) 4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) ALLYL HEPTANOATE (UNII: AU4CYG9V68) BENTONITE (UNII: A3N5ZCN45C) RASPBERRY SEED OIL (UNII: 9S8867952A) LEVOMENOL (UNII: 24WE03BX2T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-048-01 177 mL in 1 CAN; Type 0: Not a Combination Product 12/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/01/2018 Labeler - COOLA, LLC (956990290)
