COOLA FULL SPECTRUM 360 SUN SILK DROPS 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 Full Spectrum 360 Sun Silk Drops SPF 30

DRUG FACTS

Active ingredients

Avobenzone 2.0%, Homosalate 10.0%

Octisalate 5.0%, Octocrylene 6.0%

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 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

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 information
* protect this product from excessive heat and direct sun

Questions or comments? Call 760-940-2125

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.

SILK SUN DROPS 30 ML BOTTLESUN SILK DROPS 1 FL SPF 30

COOLA FULL SPECTRUM 360 SUN SILK DROPS  SPF 30
avobenzone,homosalate, octisalate,octocrylene liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-620
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21839-620-021 in 1 NOT APPLICABLE12/20/2018
1NDC:21839-620-015 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:21839-620-041 in 1 CARTON12/20/2018
2NDC:21839-620-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/20/2018
Labeler - Gordon Laboratories, Inc. (008328619)
Registrant - Gordon Laboratories, Inc. (008328619)
Establishment
NameAddressID/FEIBusiness Operations
GORDON LABORATORIES,INC008328619manufacture(21839-620)

Revised: 12/2019
Document Id: 9a03c1f7-098f-035d-e053-2a95a90a1fef
Set id: 9a03c1f7-098e-035d-e053-2a95a90a1fef
Version: 1
Effective Time: 20191218
 
Gordon Laboratories, Inc.