Label: COOLA SUN SILK DROPS SPF 30- avobenzone 3%, octisalate 4%, octocrytene 8% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 79753-038-01 - Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 7, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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
- QUESTIONS
- COOLA Label
-
INGREDIENTS AND APPEARANCE
COOLA SUN SILK DROPS SPF 30
avobenzone 3%, octisalate 4%, octocrytene 8% liquidProduct 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)
