COOLA MINERAL SUN SILK CREME SUNSCREEN SPF 30- zinc oxide lotion

COOLA Mineral Sun Silk Creme Sunscreen by

Drug Labeling and Warnings

COOLA Mineral Sun Silk Creme Sunscreen by is a Otc medication manufactured, distributed, or labeled by GORDON LABORATORIES,INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredients

Zinc Oxide 15%

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 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 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 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-sleeve 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, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Didecyldimonium Chloride, Dimethicone, Glyceryl Caprylate, Glyceryl Stearate Citrate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Jasminum Sambac Leaf Cell Extract, Methylpropanediol, Niacinamide, PEG-7 Trimethylolpropane Coconut Ether, Polyhydroxystearic Acid, Polyisobutene, Polyquaternium-80, Propanediol, Schinus Molle Extract, Theobroma Cacao (Cocoa) Seed Extract.

OTHER SAFETY INFORMATION

Other information

* protect this product from excessive heat and direct sun

QUESTIONS

Questions or comments? Call 760-940-2125

INSTRUCTIONS FOR USE

How to use:

Apply daily to cleansed skin,

15 minutes before sun exposure.

Dispense into palm of hand and

apply evenly across face and

neck using upward strokes,

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLA MINERAL SUN SILK CREME SUNSCREEN  SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21839-550
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCOA (UNII: D9108TZ9KG)
SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
NIACINAMIDE (UNII: 25X51I8RD4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PROPANEDIOL (UNII: 5965N8W85T)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21839-550-01	1 in 1 BOX	12/11/2018
1	NDC: 21839-550-02	44 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 not final	part352	12/11/2018

Labeler - GORDON LABORATORIES,INC (008328619)

Registrant - GORDON LABORATORIES,INC (008328619)

Establishment
Name	Address	ID/FEI	Business Operations
GORDON LABORATORIES,INC		008328619	manufacture(21839-550)