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%

Purpose

Sunscreen

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

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.

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 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 information

* protect this product from excessive heat and direct sun

Questions or comments? Call 760-940-2125

Refreshing Water Mist sunscreen bottle image

Refreshing Water Mist sunscreen carton image

COOLA REFRESHING WATER MIST SUNSCREEN  SPF 30
avobenzone, homosalate, octisalate, octocrylene liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-570
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE55 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21839-570-111 in 1 CARTON12/31/2018
1NDC:21839-570-1260 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/31/2018
Labeler - GORDON LABORATORIES,INC (008328619)
Registrant - GORDON LABORATORIES,INC (008328619)
Establishment
NameAddressID/FEIBusiness Operations
GORDON LABORATORIES,INC008328619manufacture(21839-570)

Revised: 12/2019
Document Id: 99d9daba-c194-a16b-e053-2a95a90ab3be
Set id: 998b6c00-1211-37b9-e053-2a95a90abed5
Version: 2
Effective Time: 20191216
 
GORDON LABORATORIES,INC