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. 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%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

* helps prevent sunburn

* if used as directed with other sun protection measures (see Directions), decreases the rise 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. If prodcut is swallowed, get medical help or contact Poison Control Center right away.

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. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

* shake well * 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 aging. To decrease this rise, regularly use a sunscreen with a broad spectrum 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-sleve shirts, pants, hats, and sunglasses

* children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Aloe Barbadensis Leaf Juice (ORGANIC), Butylene Glycol, Caprylyl Glycol, Ceteareth-12, Ceteareth-20, Cetearyl Alcohol, Cetearyl Isononanoate, Cetyl Palmitate, Citronellyl Acetate, Cocos Nucifera (ORGANIC Coconut) Water, Cyclamen Aldehyde, Ethylene Brassylate, Glycerin (ORGANIC), Glyceryl Stearate, Glycine Soja (Soybean) Extract, Hyaluronic Acid, Jasminum Sambac Leaf Cell Extract, Lauryl Glucoside, Methyl Dihydrojasmonate, Methylenedioxyphenyl Methylpropanal, Olive Oil Polyglyceryl-6 Esters, 1,2-Hexanediol, Propanediol, Schinus Molle Extract, Sodium Phytate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tropolone

OTHER SAFETY INFORMATION

Other information

* protect this product from excessive heat and direct sun

QUESTIONS

Questions or comments? Call 760-940-2125

PRINCIPAL DISPLAY PANEL

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: 21839-570
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	55 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21839-570-11	1 in 1 CARTON	12/31/2018
1	NDC: 21839-570-12	60 mL in 1 BOTTLE; Type 0: Not a Combination Product

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(21839-570)