COOLA REFRESHING WATER MIST SUNSCREEN SPF 30- avobenzone,homosalate, octisalate,octocrylene liquid
Gordon Laboratories, Inc.

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.

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COOLA Refreshing Water Mist Sunscreen SPF 30

Active Ingredients - Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.5%

Questions or comments? Call 760-940-2125

Directions: SHAKE WELL before use. With your eyes completely closed, mist face evenly, holding bottle 6-10 inces away from face. Allow to fully dry.

* Featuring Plant Cell Cultures, Coconut Water & hyaluronic Acid

* Alcohol Free

* Anti-Pollution

* UVA/UVB/IR/HEV

* Broad Spectrum SPF 30

* Dermatologist tested

* Gluten Free

* Non-GMO

NOT FOR SALE .34 FL OZ / 10 mL

Refreshing Water Mist 10 mL Sample

COOLA REFRESHING WATER MIST SUNSCREEN SPF 30
avobenzone,homosalate, octisalate,octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21839-590
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	55 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ETHYL OLIVATE (UNII: KKJ108Y20W)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
TROPOLONE (UNII: 7L6DL16P1T)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
COCONUT WATER (UNII: 267F5Y81NT)
CETEARETH-12 (UNII: 7V4MR24V5P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHYTATE SODIUM (UNII: 88496G1ERL)
PROPANEDIOL (UNII: 5965N8W85T)
JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ALCOHOL (UNII: 3K9958V90M)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
COCOA (UNII: D9108TZ9KG)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SOYBEAN (UNII: L7HT8F1ZOD)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:21839-590-03	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/31/2018

Labeler - Gordon Laboratories, Inc. (008328619)

Registrant - Gordon Laboratories, Inc. (008328619)

Name	Address	ID/FEI	Business Operations
Establishment
GORDON LABORATORIES,INC		008328619	manufacture(21839-590)