Otc - Active Ingredient
Drug Facts
Active Ingredients
Zinc Oxide 17.9%
The following Structured Product Label (SPL) was submitted to the FDA by Coola Llc for the product Bare Republic Mineral Spf 50 (NDC 79753-069). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active Ingredients
Zinc Oxide 17.9%
Purpose
Suncreen
Uses
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 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 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 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 information
Questions or comments?
Call 760-940-2125
BARE
REPUBLIC®
Sheer Zinc Oxide
Sunscreen Lotion
0.9 OZ
25 g
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LLC, located in sunny San Diego, CA 92009. All Rights
Reserved. WWW.GOBAREOUTSIDE.COM
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