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DRUG FACTS
Bare Republic Big Adventure Stick Spf 70 Stick
FDA Label NDC 79753-026
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Coola for the product Bare Republic Big Adventure Stick Spf 70 (NDC 79753-026). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients
Titanium Dioxide 3.5% Zinc Oxide 16.9%
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
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
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes.
Rinse with water to remove.
Otc - Stop Use
Stop use and ask doctor if skin rash occurs
Otc - 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.
Dosage & Administration
Directions
Apply liberally 15 minutes before sun exposure
• reapply: • after 80 minutes 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 after 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
Helianthus Annuus (Sunflower) Seed Wax,
Neopentyl Glycol Diheptanoate, C12-15 Alkyl
Benzoate, Isododecane, Behenyl Behenate,
Caprylic/Capric Triglyceride, Lauryl Laurate,
Polyhydroxystearic Acid, Butyrospermum Parkii
(Shea) Butter, Ethylhexyl Methoxycrylene, Methyl
Dihydroabietate, Stearyl/Octyldodecyl Citrate
Crosspolymer, Polymethylsilsesquioxane,
Trimethoxybenzylidene Pentanedione, Triethyl
Citrate, Ethyl Ferulate, Triethoxycaprylylsilane,
1,2-Hexanediol, Caprylyl Glycol, Euphorbia Cerifera
(Candelilla) Wax, Stearic Acid, Alumina,
Gamma-Decalactone, Raspberry Ketone, Isostearic
Acid, Vanillin, Gamma-Nonalactone, Gamma
Octalactone, Lecithin, Polyglyceryl-3 Polyricinoleate,
Allyl Heptoate, Heliotropine, Vitis Vinifera (Grape)
Seed Extract, Daucus Carota Sativa (Carrot) Root
Extract, Rubus Idaeus (Raspberry) Fruit Extract.
Other Safety Information
Other Information
- protect this product from excessive heat and direct sun
- may stain fabrics
Otc - Questions
Questions or Comments? Call 760-940-2125
Package For Bare Republic Mineral Sunscreen Stick
SPF 70
BARE
REPUBLIC ®
MINERAL
Sunscreen Stick
2.0 OZ / 56 g
Distributed by:
COOLA LLC, Located in Sunny &
Cool San Diego, CA 92009.
WWW.GOBAREOUTSIDE.COM
Coola-026 (Coola 026)
res
* Please review the disclaimer below.
