COOLA FULL SPECTRUM 360 SUN SILK DROPS SPF 30- avobenzone,homosalate, octisalate,octocrylene liquid

COOLA Full Spectrum 360 Sun Silk Drops by

Drug Labeling and Warnings

COOLA Full Spectrum 360 Sun Silk Drops 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]

DRUG FACTS

Active ingredients

Avobenzone 2.0%, Homosalate 10.0%

Octisalate 5.0%, Octocrylene 6.0%

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

Aloe Barbadensis Leaf Extract (Organic), Anthemis Nobilis (Chamomile) Flower Oil, Butylene Glycol, Butyloctyl Salicylate, Calcium Gluconate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Organic Safflower) Seed Oil, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Extract, Dicaprylyl Carbonate, Glycerin (Organic), Glyceryl Stearate Se, Jasminum Sambac (Jasmine) Leaf Cell Extract, Nylon-12, Olea Europaea (Organic Olive) Fruit Oil, Plankton Leaf Extract, Propanediol, Schinus Molle Extract, Simmondsia Chinensis (Organic Jojoba) Seed Oil, Sodium Benzoate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

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. For best

results, dispense several drops as needed

into palm of hand and apply evenly across

face and neck using upward strokes. Drops

are perfect for use alone or blended with

your everyday skincare and makeup.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLA FULL SPECTRUM 360 SUN SILK DROPS  SPF 30
avobenzone,homosalate, octisalate,octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21839-620
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPANEDIOL (UNII: 5965N8W85T)
OLIVE OIL (UNII: 6UYK2W1W1E)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCOA (UNII: D9108TZ9KG)
SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)
JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)
SAFFLOWER OIL (UNII: 65UEH262IS)
NYLON-12 (UNII: 446U8J075B)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
XANTHAN GUM (UNII: TTV12P4NEE)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21839-620-02	1 in 1 NOT APPLICABLE	12/20/2018
1	NDC: 21839-620-01	5 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 21839-620-04	1 in 1 CARTON	12/20/2018
2	NDC: 21839-620-03	30 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	12/20/2018

Labeler - Gordon Laboratories, Inc. (008328619)

Registrant - Gordon Laboratories, Inc. (008328619)

Establishment
Name	Address	ID/FEI	Business Operations
GORDON LABORATORIES,INC		008328619	manufacture(21839-620)