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

COOLA Refreshing Water Mist Sunscreen by

Drug Labeling and Warnings

COOLA Refreshing Water Mist Sunscreen by is a Otc medication manufactured, distributed, or labeled by Gordon Laboratories, Inc., GORDON LABORATORIES,INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

QUESTIONS

Questions or comments? Call 760-940-2125

INDICATIONS & USAGE

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.

DESCRIPTION

* 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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Gordon Laboratories, Inc. (008328619)

Registrant - Gordon Laboratories, Inc. (008328619)

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