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): 21839-590-03 - Packager: Gordon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated December 26, 2019
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- ACTIVE INGREDIENT
- QUESTIONS
- INDICATIONS & USAGE
- DESCRIPTION
- NOT FOR SALE .34 FL OZ / 10 mL
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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:21839-590 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 55 mg in 1 mL Inactive Ingredients Ingredient Name Strength ETHYL OLIVATE (UNII: KKJ108Y20W) CETYL PALMITATE (UNII: 5ZA2S6B08X) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) TROPOLONE (UNII: 7L6DL16P1T) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETEARYL ISONONANOATE (UNII: P5O01U99NI) COCONUT WATER (UNII: 267F5Y81NT) CETEARETH-12 (UNII: 7V4MR24V5P) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHYTATE SODIUM (UNII: 88496G1ERL) PROPANEDIOL (UNII: 5965N8W85T) JASMINUM SAMBAC FLOWER (UNII: 2S686I937F) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BENZOIC ACID (UNII: 8SKN0B0MIM) ALCOHOL (UNII: 3K9958V90M) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) COCOA (UNII: D9108TZ9KG) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALOE VERA LEAF (UNII: ZY81Z83H0X) SOYBEAN (UNII: L7HT8F1ZOD) WATER (UNII: 059QF0KO0R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21839-590-03 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/31/2018 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(21839-590)