Label: BABY BARE REPUBLIC MINERAL SUNSCREEN SOFTSTICK SPF 50- zinc oxide stick
- NDC Code(s): 79753-009-01
- Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2023
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- Official Label (Printer Friendly)
- 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 spection SPF of 15 or higher and other sun protection
measures including: SPF of 15 or higher and other sun protection
● 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 IngredientsButyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethyl Ferulate, Gossypium Herbaceum (Cotton) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydrogenated Rapeseed Oil, Isododecane, Neopentyl Glycol Diheptanoate, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Stearyl Alcohol, Tocopherol, Triethoxycaprylylsilane
- OTHER SAFETY INFORMATION
- SPL UNCLASSIFIED SECTION
- COOLA Label
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INGREDIENTS AND APPEARANCE
BABY BARE REPUBLIC MINERAL SUNSCREEN SOFTSTICK SPF 50
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-009 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 SHEA BUTTER (UNII: K49155WL9Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS (UNII: R2Z4507WJN) CHAMOMILE (UNII: FGL3685T2X) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYL FERULATE (UNII: 5B8915UELW) COTTONSEED OIL (UNII: H3E878020N) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU) ISODODECANE (UNII: A8289P68Y2) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TOCOPHEROL (UNII: R0ZB2556P8) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-009-01 1 in 1 BLISTER PACK 03/03/2021 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 Drug M020 03/03/2021 Labeler - COOLA LLC (956990290) Registrant - Bentley Laboratories, LLC (068351753) Establishment Name Address ID/FEI Business Operations Bentley Laboratories, LLC 068351753 manufacture(79753-009)