Label: MINERAL SUNSCREEN STICK SPF 50 FRAGRANCE-FREE- zinc oxide stick
- NDC Code(s): 79753-032-01
- Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
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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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
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
Helianthus Annus (Sunflower) Seed Oil (ORGANIC), caprylic/Capric Triglyceride
(ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Ozokerite,
Polymethylsilsesquioxane, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica,
Trimethoxybenzylidene Pentanedione, Butyrospermum Parkii (Shea) Butter (ORGANIC),
1,2-Heanediol Dimethicone, Ethyl Ferulate, Triethoxycaprylylsilane, Polyhydroxystearic
Acid, Limnanthese Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa Fruit Oil (ORGANIC),
Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Optuntia Ficus-Indica Seed Oil (ORGANIC) - OTHER SAFETY INFORMATION
- QUESTIONS
-
COOLA Label
SPF
50
70%+
Organic
COOLA®
Classic
Sunscreen Stick
Fragrance-Free
Broad Spectrum SPF 50
Water-Resistant (80 Minutes)
+Plant Protection®
Net Wt. 0.6 OZ / 17.0 g
©2022 COOLA. Manufactured in the USA for COOLA, located in
Sunny & Cool San Diego, CA 92010. All Rights Reserved. Questions or
Comments? Call 760-940-2125. www.coola.com
res
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INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN STICK SPF 50 FRAGRANCE-FREE
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 13.63 g in 100 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARNAUBA WAX (UNII: R12CBM0EIZ) CERESIN (UNII: Q1LS2UJO3A) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25) SHEA BUTTER (UNII: K49155WL9Y) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYL FERULATE (UNII: 5B8915UELW) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) RASPBERRY SEED OIL (UNII: 9S8867952A) OPUNTIA FICUS-INDICA WHOLE (UNII: 23Z87HTQ6P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-032-01 1 in 1 CARTON 01/16/2023 1 17 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)