Label: COOLA CLASSIC BODY SUNSCREEN FRAGRANCE-FREE SPF 50- avobenzone,homosalate, octisalate,octocrylene lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 21839-430-01, 21839-430-02 - 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
-
DOSAGE & ADMINISTRATION
Directions
* 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 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-sleve shirts, pants, hats, and sunglasses
* children under 6 months: Ask a doctor -
INACTIVE INGREDIENT
Inactive ingredients
Aloe Barbadensis Leaf Juice (ORGANIC), Blue-Green (Algae) Extract (ORGANIC), Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Chlorphenesin, Cocos Nucifera (Coconut) Oil (ORGANIC), Ethylhexylglycerin, Glycerin (ORGANIC), Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Magnesium Sulfate, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Neopentyl Glycol Diheptanoate, Olive Oil Polyglyceryl-6 Esters, Opuntia Ficus-Indica Flower Extract, Polyglyceryl-6 Pentaoleate, Polymethyl Methacrylate, Rubus Idaeus (Raspberry) Seed Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, VP/Hexadecene Copolymer.
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
COOLA CLASSIC BODY SUNSCREEN FRAGRANCE-FREE SPF 50
avobenzone,homosalate, octisalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21839-430 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 17.5 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 20 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) TROPOLONE (UNII: 7L6DL16P1T) PHYTATE SODIUM (UNII: 88496G1ERL) ALOE VERA LEAF (UNII: ZY81Z83H0X) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CANOLA OIL (UNII: 331KBJ17RK) ALCOHOL (UNII: 3K9958V90M) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) SODIUM BENZOATE (UNII: OJ245FE5EU) RASPBERRY SEED OIL (UNII: 9S8867952A) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TOCOPHEROL (UNII: R0ZB2556P8) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) HEXYLENE GLYCOL (UNII: KEH0A3F75J) GLUCONOLACTONE (UNII: WQ29KQ9POT) CARTHAMUS TINCTORIUS SEEDCAKE (UNII: DHQ13F4N2W) DIMETHICONE (UNII: 92RU3N3Y1O) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) GLYCERIN (UNII: PDC6A3C0OX) SAFFLOWER OIL (UNII: 65UEH262IS) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAMELINA SATIVA SEED OIL (UNII: 12824X01L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21839-430-02 1 in 1 CARTON 02/28/2019 1 NDC:21839-430-01 148 mL in 1 TUBE; 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 02/28/2019 Labeler - Gordon Laboratories, Inc. (008328619) Registrant - Gordon Laboratories, Inc. (008328619) Establishment Name Address ID/FEI Business Operations GORDON LABORATORIES,INC 008328619 manufacture(21839-430)
