BARE REPUBLIC SPF 50 MINERAL SUNSCREEN VANILLA COCO- titanium dioxide, zinc oxide spray

Bare Republic SPF 50 Mineral Sunscreen Vanilla Coco by

Drug Labeling and Warnings

Bare Republic SPF 50 Mineral Sunscreen Vanilla Coco by is a Otc medication manufactured, distributed, or labeled by COOLA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide - 4.3%

Zinc Oxide - 15.0%

PURPOSE

Sunscreen

Uses

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.

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

• May stain fabrics
• Protect this product from excessive heat and direct sun

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

Call 760-940-2125

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BARE REPUBLIC SPF 50 MINERAL SUNSCREEN VANILLA COCO 
titanium dioxide, zinc oxide spray

Product 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)