Label: BARE REPUBLIC MINERAL SPF 50- zinc oxide stick
- NDC Code(s): 79753-069-01
- Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 25, 2023
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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
● 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 -
INACTIVE INGREDIENT
Inactive Ingredients
Neopentyl Glycol Diheptanoate, Isododecane, Caprylic/Capric Triglyceride, Hydrogenated Rapeseed Oil,
Polymethylsilsesquioxane, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Wax, Butyrospermum Parkii (Shea) Butter,
Gossypium Herbaceum (Cotton) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria)
Flower Extract, Tocopherol, Dimethicone, Ethyl Ferulate, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Fragrance (Natural) - OTHER SAFETY INFORMATION
- QUESTIONS
- COOLA Label
-
INGREDIENTS AND APPEARANCE
BARE REPUBLIC MINERAL SPF 50
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-069 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 17.9 g in 100 g Inactive Ingredients Ingredient Name Strength NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) ISODODECANE (UNII: A8289P68Y2) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYL FERULATE (UNII: 5B8915UELW) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TOCOPHEROL (UNII: R0ZB2556P8) SHEA BUTTER (UNII: K49155WL9Y) LEVANT COTTONSEED OIL (UNII: N5CFT140R8) SAFFLOWER OIL (UNII: 65UEH262IS) CHAMOMILE (UNII: FGL3685T2X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-069-01 1 in 1 CARTON 01/16/2023 1 25 g in 1 CANISTER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/16/2023 Labeler - COOLA LLC (956990290)
