COOLA SUN SILK DROPS SPF 30- avobenzone 3%, octisalate 4%, octocrytene 8% liquid

COOLA Sun Silk Drops SPF 30 by

Drug Labeling and Warnings

COOLA Sun Silk Drops SPF 30 by is a Otc medication manufactured, distributed, or labeled by COOLA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

Avobenzone 3%, Octisalate 4%, Octocrylene 8%

Purpose

Suncreen

INDICATIONS & USAGE

Uses

• helps prevent sunburn

• if used as directed with other sun protection

    measures (see Directions), decreases the risk of skin

    cancer and early skin aging caused by the sun

WARNINGS

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

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 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 skin 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),
Butyloctyl Salicylate, Glycerin (ORGANIC),
Polyglyceryl-6 Stearate, Carthamus Tinctorius
(Safflower) Seed Oil (ORGANIC), Olea Europaea
(Olive) Fruit Oil (ORGANIC), Simmondsia Chinensis
(Jojoba) Seed Oil (ORGANIC), Theobroma Cacao
(Cocoa) Seed Extract, Jasminum Sambac
(Jasmine) Leaf Cell Extract, Schinus Molle Extract,
Sodium Hyaluronate, Sodium Hydroxide, Plankton
Extract, Water, Ethyl Ferulate, Propanediol,
Butylene Glycol, 1,2-Hexanedipol, Caprylyl Glycol,
Glyceryl Stearate, Hydroxyacetophenone,
Polyglyceryl-6 Behenate, Acrylates/10-30 Alkyl
Acrylate Crosspolymer, Sodium Phylae,
Tocopheryl Acetate, Fragrance (Natural)

OTHER SAFETY INFORMATION

Other information

• protect this product from excessive heat and direct sun

QUESTIONS

Questions or comments?  Call 760-940-2125

COOLA Label

SPF

30

70%+

Organic

COOLA​®

Sun Silk Drops

Sunscreen

1.0 FL OZ / 30 mL

*SPF value may decrease if blended.

For detailed instructions, see insert.

©2021 COOLA. Distributed by: COOLA LLC,

located in Sunny & Cool San Diego, CA 92010. 

All Rights Reserved. 

www.coola.com

Carton

Bottle

res

INGREDIENTS AND APPEARANCE

COOLA SUN SILK DROPS SPF 30 
avobenzone 3%, octisalate 4%, octocrytene 8% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS (UNII: R2Z4507WJN)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
COCOA (UNII: D9108TZ9KG)
JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)
SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)
WATER (UNII: 059QF0KO0R)
ETHYL FERULATE (UNII: 5B8915UELW)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PHYTATE SODIUM (UNII: 88496G1ERL)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-038-01	1 in 1 CARTON	09/01/2021
1		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 not final	part352	09/01/2021

Labeler - COOLA LLC (956990290)