COOLA CLASSIC FACE SUNSCREEN FRAGRANCE-FREE SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
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 Classic Face Sunscreen Fragrance-Free SPF 50

Active Ingredients

AVOBENZONE 1.75%, HOMOSALATE 5.0%, OCTISALATE 2.0%, OCTOCRYLENE 5.0%

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 product 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

* apply liberally 15 minutes before sun exposure

* reapply:

* after 80 minutes of 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 risk, 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), Brassica Campestris (Rapeseed) Seed Oil, Butylene Glycol, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Carthamus Tinctorius (Safflower) Seedcake Extract, Decyl Glucoside, Dimethicone, Glycerin (ORGANIC), Hydrogenated Methyl Abietata, Hydrolyzed Jojoba Esters, Jojoba Esters, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa Fruit Oil, 1,2 Hexanediol, Opuntia Ficus-Indica Flower Extract, Polyacrylate Crosspolymer-6, Polysilicone-11, Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium Phytate, Tropolone, Xanthan Gum

Other Information

* protect this product from excessive heat and direct sun

Questions or comments? Call 760-940-2125

Classic Face Sunscreen Frag Free SPF 50 tubeClassic Face Sunscreen Frag Free SPF 50 carton

COOLA CLASSIC FACE SUNSCREEN FRAGRANCE-FREE  SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-452
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE17.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
TROPOLONE (UNII: 7L6DL16P1T)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALCOHOL (UNII: 3K9958V90M)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
CARTHAMUS TINCTORIUS SEEDCAKE (UNII: DHQ13F4N2W)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)  
CANOLA OIL (UNII: 331KBJ17RK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21839-452-021 in 1 CARTON12/31/2018
1NDC:21839-452-01148 mL in 1 TUBE; 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(21839-452)

Revised: 12/2019
Document Id: 9aa31cf2-f6f0-8a57-e053-2a95a90a1faf
Set id: 9aa2c886-fd7c-7741-e053-2995a90a6e65
Version: 1
Effective Time: 20191226
 
Gordon Laboratories, Inc.