Label: COOLA REFRESHING WATER MIST SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 21839-570-11, 21839-570-12 - Packager: GORDON LABORATORIES,INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 16, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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 rise, 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-sleve shirts, pants, hats, and sunglasses
* children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Inactive ingredients
Aloe Barbadensis Leaf Juice (ORGANIC), Butylene Glycol, Caprylyl Glycol, Ceteareth-12, Ceteareth-20, Cetearyl Alcohol, Cetearyl Isononanoate, Cetyl Palmitate, Citronellyl Acetate, Cocos Nucifera (ORGANIC Coconut) Water, Cyclamen Aldehyde, Ethylene Brassylate, Glycerin (ORGANIC), Glyceryl Stearate, Glycine Soja (Soybean) Extract, Hyaluronic Acid, Jasminum Sambac Leaf Cell Extract, Lauryl Glucoside, Methyl Dihydrojasmonate, Methylenedioxyphenyl Methylpropanal, Olive Oil Polyglyceryl-6 Esters, 1,2-Hexanediol, Propanediol, Schinus Molle Extract, Sodium Phytate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tropolone
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLA REFRESHING WATER MIST SUNSCREEN SPF 30
avobenzone, homosalate, octisalate, octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21839-570 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 55 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) JASMINUM SAMBAC FLOWER (UNII: 2S686I937F) SOYBEAN (UNII: L7HT8F1ZOD) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) CETEARETH-12 (UNII: 7V4MR24V5P) BENZOIC ACID (UNII: 8SKN0B0MIM) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHYTATE SODIUM (UNII: 88496G1ERL) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) TROPOLONE (UNII: 7L6DL16P1T) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCOA (UNII: D9108TZ9KG) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4) ETHYL OLIVATE (UNII: KKJ108Y20W) COCONUT WATER (UNII: 267F5Y81NT) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PROPANEDIOL (UNII: 5965N8W85T) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) CETEARYL ISONONANOATE (UNII: P5O01U99NI) CETYL PALMITATE (UNII: 5ZA2S6B08X) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21839-570-11 1 in 1 CARTON 12/31/2018 1 NDC:21839-570-12 60 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 12/31/2018 Labeler - GORDON LABORATORIES,INC (008328619) Registrant - GORDON LABORATORIES,INC (008328619) Establishment Name Address ID/FEI Business Operations GORDON LABORATORIES,INC 008328619 manufacture(21839-570)