Label: COOLA CLASSIC FACE SUNSCREEN FRAGRANCE-FREE SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 21839-452-01, 21839-452-02 - 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 26, 2019
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
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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), Brassica Campestris (Rapeseed) Seed Oil, Butylene Glycol, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Carthamus Tinctorius (Safflower) Seedcake Extract, Decyl Glucoside, Dimethicone, Glycerin (ORGANIC), Hydrogenated Methyl Abietata, Hydrolyzed Jojoba Esters, Jojoba Esters, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa Fruit Oil, 1,2 Hexanediol, Opuntia Ficus-Indica Flower Extract, Polyacrylate Crosspolymer-6, Polysilicone-11, Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium Phytate, Tropolone, Xanthan Gum
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLA CLASSIC FACE SUNSCREEN FRAGRANCE-FREE SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21839-452 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 17.5 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) 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) CANOLA OIL (UNII: 331KBJ17RK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21839-452-02 1 in 1 CARTON 12/31/2018 1 NDC:21839-452-01 148 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 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(21839-452)
