COOLA FULL SPECTRUM 360 REFRESHING WATER CREAM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

COOLA Full Spectrum 360 Refreshing Water Cream SPF 50 by

Drug Labeling and Warnings

COOLA Full Spectrum 360 Refreshing Water Cream SPF 50 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 3.0%, Octocrylene 5.0%

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.

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 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
Adipic Acid/Diglycol Crosspolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, (ORGANIC)
Anisaldehyde*, Argania Spinosa Kernel Oil, Benzyl Acetate*, Bisabolol, Butylene Glycol, Caprylhydroxamic Acid,
Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Citric Acid, Coccinia Indica Fruit Extract, Cocos Nucifera
(Coconut) Water (ORGANIC), Corallina Officinalis Extract, Curcuma Longa (Turmeric) Root Extract, Delta-Decalactone*,
Ethyl Butyrate*, Gamma-Nonalactone*, Gamma-Octalactone*, Gluconolactone, Glycerin (ORGANIC), Glyceryl Caprylate,
Glyceryl Stearate, Heliotropine*, Hyaluronic Acid, Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Juniperus
Mexicana, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Leuconostoc Ferment Filtrate, Melia Azadirachta Flower
Extract, Melia Azadirachta Leaf Extract, Methyl Anthranilate*, Methyl Benzoate*, Methyl Benzyl Acetate*, Mimosa
Tenuiflora Bark Extract, Neopentyl Glycol Diheptanoate, Nerolidol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum
Sanctum Leaf Extract, Phenethyl Alcohol*, Propanediol, Schinus Molle Extract, Sodium Acrylates Copolymer, Sodium
Benzoate, Sodium Hydroxide, Sodium Stearoyl Glutamate, Solanum Melongena (Eggplant) Fruit Extract, Theobroma
Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Triethyl Citrate*, Vanillin, Water, 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

50

70%+

Organic

COOLA​®

Refreshing Water Cream

Sunscreen

1.5 FL OZ / 44 mL

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 FULL SPECTRUM 360 REFRESHING WATER CREAM SPF 50 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-020
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	3.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
P-ANISALDEHYDE (UNII: 9PA5V6656V)
ARGAN OIL (UNII: 4V59G5UW9X)
BENZYL ACETATE (UNII: 0ECG3V79ZJ)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCCINIA GRANDIS LEAF (UNII: YJE89UL5PL)
COCONUT WATER (UNII: 267F5Y81NT)
CORALLINA OFFICINALIS (UNII: 4004498D06)
TURMERIC (UNII: 856YO1Z64F)
.DELTA.-DECALACTONE (UNII: CNA0S5T234)
ETHYL BUTYRATE (UNII: UFD2LZ005D)
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PIPERONAL (UNII: KE109YAK00)
HYALURONIC ACID (UNII: S270N0TRQY)
ISODODECANE (UNII: A8289P68Y2)
JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
METHYL ANTHRANILATE (UNII: 981I0C1E5W)
METHYL BENZOATE (UNII: 6618K1VJ9T)
METHYLBENZYL ACETATE (UNII: P4RVP859F5)
MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
NEROLIDOL (UNII: QR6IP857S6)
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)
HOLY BASIL LEAF (UNII: SCJ765569P)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
PROPANEDIOL (UNII: 5965N8W85T)
SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)
SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) (UNII: N30934870L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
EGGPLANT (UNII: W5K7RAS4VK)
COCOA (UNII: D9108TZ9KG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
VANILLIN (UNII: CHI530446X)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-020-01	1 in 1 CARTON	02/08/2021
1		44 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 79753-020-02	1 in 1 CARTON	02/08/2021
2		15 mL in 1 JAR; 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)