Label: COOLA CLASSIC SUNSCREEN STICK SPF 30 - TROPICAL COCONUT- avobenzone 3.0%, octisalate 4.0%, octocrytene 7.0% stick
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Contains inactivated NDC Code(s)
NDC Code(s): 79753-016-01 - Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 6, 2021
If you are a consumer or patient please visit this version.
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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:
● 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
1,2-Hexanediol, Bisabolol, Bis-Octyldodecyl Dimer Dilinoleate/Propanediol Copolymer,
Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Camellia Oleifera
Seed Oil (ORGANIC), Caprylic/Capric Triglyceride (ORGANIC), Carthamus Tinctorius
(Safflower) Seed Oil (ORGANIC), Dimethyl Heptenal*, Gamma-Nonalactone*,
Gamma-Octalactone*, Hydroxystearic Acid, Limnanthes Alba (Meadowfoam) Seed Oil,
Maltol*, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract,
Polyester-8, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Silica Dimethyl Silylate,
Trans-2-Hexenal*, Triethyl Citrate*, VANILLIN* OR VANADIUM*???* - OTHER SAFETY INFORMATION
- SPL UNCLASSIFIED SECTION
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COOLA Label
SPF
30
70%+
Organic
COOLA®
Classic
Sunscreen Stick
Tropical Coconut
Broad Spectrum SPF 30
Water Resistant (80 Minutes)
+Plant Protection®
0.6 OZ / 17.0 g
©2021 COOLA. Distributed by: COOLA LLC, located in Sunny &
Cool San Diego, CA 92010. All Rights Reserved. www.coola.com
Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
*Plant-derived scent constituent. See coola.com for additional detail.Carton
Canister
res
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INGREDIENTS AND APPEARANCE
COOLA CLASSIC SUNSCREEN STICK SPF 30 - TROPICAL COCONUT
avobenzone 3.0%, octisalate 4.0%, octocrytene 7.0% stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.0 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.0 g in 100 g Inactive Ingredients Ingredient Name Strength 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LEVOMENOL (UNII: 24WE03BX2T) BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R) BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626) CAMELINA SATIVA SEED OIL (UNII: 12824X01L0) CAMELLIA OIL (UNII: T1PE06G0VE) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SAFFLOWER OIL (UNII: 65UEH262IS) 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) 10-HYDROXYSTEARIC ACID (UNII: 384M5B7IFL) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) MALTOL (UNII: 3A9RD92BS4) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) OPUNTIA FICUS-INDICA LEAF (UNII: 5VM709H93V) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) RASPBERRY SEED OIL (UNII: 9S8867952A) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) 2-HEXENAL, (2E)- (UNII: 69JX3AIR1I) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) VANILLIN (UNII: CHI530446X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-016-01 1 in 1 CARTON 02/08/2021 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 not final part352 02/08/2021 Labeler - COOLA LLC (956990290)