Label: COOLA CLASSIC BODY SUNSCREEN SPF 70 - PEACH BLOSSOM- avobenzone, homosalate, octisalate, octocrylene cream
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- NDC Code(s): 79753-015-01
- 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 21, 2021
If you are a consumer or patient please visit this version.
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- 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
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, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice (ORGANIC), Benzyl Alcohol, Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Butyloctyl Salicylate, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Citric Acid, Cocos Nucifera (Coconut) Oil*, Decanal*, Dimethyl Heptenal*, Ethyl Acetoacetate*, Ethyl Butyrate*, Ethyl Caproate*, Gamma-Nonalactone*, Gamma Undecalactone*, Gluconolactone, Glycerin (ORGANIC), Hexenyl Acetate*, Hexyl Acetate*, Hydroxyacetophenone, Isoamyl Acetate*, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Opuntia Ficus-Indica Flower Extract, Pentylene Glycol, Polyacrylate Crosspolymer-6, Prunus Persica (Peach) Flower Extract, Raspberry Ketone*, Rubus Idaeus (Raspberry) Seed Oil, Sodium Benzoate, Sodium Hydroxide, Sodium Phytate, Triethyl Citrate*, Xanthan Gum - OTHER SAFETY INFORMATION
- QUESTIONS
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COOLA Label
SPF
70
70%+
Organic
COOLA®
Classic
Body Sunscreen
Peach Blossom
Ultra Lightweight
Hydrates & Nourishes
+Plant Protection®
Broad Spectrum SPF 70
Water Resistant (80 Minutes)
5.0 FL OZ / 148 mL
©2021 COOLA. Distributed by: COOLA LLC, located in
Sunny & Cool San Diego, CA 92010. All Rights Reserved.
Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
*Plant-derived scent constituent. See coola.com for additional detail.Carton
Bottle
res
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INGREDIENTS AND APPEARANCE
COOLA CLASSIC BODY SUNSCREEN SPF 70 - PEACH BLOSSOM
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-015 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 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.0 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 1,2-HEXANEDIOL (UNII: TR046Y3K1G) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) LEVOMENOL (UNII: 24WE03BX2T) BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAMELINA SATIVA SEED OIL (UNII: 12824X01L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) SAFFLOWER OIL (UNII: 65UEH262IS) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCONUT OIL (UNII: Q9L0O73W7L) DECANAL (UNII: 31Z90Q7KQJ) 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) ETHYL ACETOACETATE (UNII: IZP61H3TB1) ETHYL BUTYRATE (UNII: UFD2LZ005D) ETHYL CAPROATE (UNII: FLO6YR1SHT) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL) GLUCONOLACTONE (UNII: WQ29KQ9POT) GLYCERIN (UNII: PDC6A3C0OX) HEXENYL ACETATE, (2Z)- (UNII: PT792BQ57D) HEXYL ACETATE (UNII: 7U7KU3MWT0) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ISOAMYL ACETATE (UNII: Z135787824) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) OPUNTIA FICUS-INDICA LEAF (UNII: 5VM709H93V) PENTYLENE GLYCOL (UNII: 50C1307PZG) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH) 4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG) RASPBERRY SEED OIL (UNII: 9S8867952A) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHYTATE SODIUM (UNII: 88496G1ERL) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-015-01 1 in 1 CARTON 02/08/2021 1 148 mL in 1 TUBE; 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)