Bare Republic Mineral Stick Sunscreen

Bare Republic Mineral Stick Sunscreen by

Drug Labeling and Warnings

Bare Republic Mineral Stick Sunscreen by is a Otc medication manufactured, distributed, or labeled by Coola, LLC, Gordon Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BARE REPUBLIC MINERAL STICK SUNSCREEN- zinc oxide 25% stick 
Coola, LLC

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.

----------

Bare Republic Mineral Stick Sunscreen

Drug Facts

Active Ingredient

Zinc Oxide 25%

Purpose

Zinc Oxide 25%.........Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection methods (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For External Use Only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if skin rash occurs

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

Directions

  • Apply liberally for 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 10a.m. - 2p.m.
  • wear long sleeve shirts, pants, hats and sunglasses
  • children under 6 months: ask a doctor.

Inactive Ingredients

Allyl Heptoate, Benzyl Alcohol, Butyloctyl Salicylate, Butryospermum Parkii (Shea) Butter, C12-C15 Alky Benzoate, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelilla) Wax, Gamma-Decalactone, Gamma-Nonalactone, Gamme-Octalactone, Glycerin, Helianthus Annnuus (Sunflower) Seed Oil, Heliotropine, Ozokerite, Polyhydroxystearic Acid, Raspberry Ketones, Rubus Idaeus (Raspberry) Extract, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherly Acetate, Triethyl Citrate, Vanillin, Vitis Vinifera (Grape) Seed Extract, Water (Aqua)

Other Information

  • may stain fabrics
  • protect this product from excessive heat and direct sun

Questions or Comments?

Call 760-940-2125

PDP

BARE REPUBLIC MINERAL STICK SUNSCREEN 
zinc oxide 25% stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79753-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
RASPBERRY (UNII: 4N14V5R27W)  
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)  
PIPERONAL (UNII: KE109YAK00)  
CERESIN (UNII: Q1LS2UJO3A)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALLYL HEPTANOATE (UNII: AU4CYG9V68)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)  
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)  
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)  
JOJOBA OIL (UNII: 724GKU717M)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
VANILLIN (UNII: CHI530446X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CANDELILLA WAX (UNII: WL0328HX19)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79753-002-011 in 1 BOX10/28/202012/31/2022
114.78 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/28/202012/31/2022
Labeler - Coola, LLC (956990290)
Establishment
NameAddressID/FEIBusiness Operations
Gordon Laboratories, Inc008328619manufacture(79753-002)

Revised: 12/2022
Document Id: f0ff6508-ecf3-10ac-e053-2a95a90acf3b
Set id: b2bba7d8-1182-0d7d-e053-2995a90a2343
Version: 2
Effective Time: 20221229
Â
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.