COOLA CLASSIC FACE SUNSCREEN FRAGRANCE-FREE SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

COOLA Classic Face Sunscreen Fragrance-Free by

Drug Labeling and Warnings

COOLA Classic Face Sunscreen Fragrance-Free 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 1.75%, HOMOSALATE 5.0%, OCTISALATE 2.0%, OCTOCRYLENE 5.0%

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 AND PRECAUTIONS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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 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 CLASSIC FACE SUNSCREEN FRAGRANCE-FREE  SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21839-452
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	17.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21839-452-02	1 in 1 CARTON	12/31/2018
1	NDC: 21839-452-01	148 mL in 1 TUBE; 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(21839-452)