COOLA CLASSIC BODY SUNSCREEN SPF 70 - PEACH BLOSSOM- avobenzone, homosalate, octisalate, octocrylene cream

COOLA Classic Body Sunscreen SPF 70 - Peach Blossom by

Drug Labeling and Warnings

COOLA Classic Body Sunscreen SPF 70 - Peach Blossom by is a Otc medication manufactured, distributed, or labeled by COOLA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

Avobenzone 3.0%, Homosalate 5.0%, Octisalate 4.9%, Octocrylene 7.5%

Purpose

Suncreen

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

Do not use on damaged or broken skin

When using this product keep out of eyes.

Rinse with water to remove.

Do not use on damaged or broken skin

Stop use and ask doctor if skin rash occurs

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 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

Other information

• protect this product from excessive heat and direct sun

QUESTIONS

Questions or comments?
Call 760-940-2125

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

INGREDIENTS AND APPEARANCE

COOLA CLASSIC BODY SUNSCREEN SPF 70 - PEACH BLOSSOM 
avobenzone, homosalate, octisalate, octocrylene cream

Product 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 Drug	M020	02/08/2021

Labeler - COOLA LLC (956990290)