Label: COOLA CLASSIC SUNSCREEN FRAGRANCE FREE- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 79753-045-72
- 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 November 1, 2021
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of the reach of children
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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
- children under 6 months of age: ask a doctor
- 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 value 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-sleeved shirts, pants, hats, and sunglasses
- Other information
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Inactive Ingredients
Alkyl Heptoate, Behenyl Alcohol, Butylated PVP, Butylene Glycol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Disodium EDTA, Ethylhexylglycerin, Gamma-Decalactone, Gamma-Nonalactone, Glycerin, Glyceryl Stearate, Heliotropine, Lauryl Alcohol, Lecithin, Linum Usitatissimum (Linseed) Seed Oil, Lycium Barbarum Fruit Extract, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Phenoxyethanol, Propylene Glycol, Raspberry Ketone, Rubus Idaeus (Raspberry) Seed Extract, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Triethyl Citrate, Vanillin, Water (Aqua)
- Label
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INGREDIENTS AND APPEARANCE
COOLA CLASSIC SUNSCREEN FRAGRANCE FREE
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-045 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) RASPBERRY SEED OIL (UNII: 9S8867952A) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) MONARDA DIDYMA LEAF (UNII: JY15982UBB) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ALLYL HEPTANOATE (UNII: AU4CYG9V68) 4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITIC ACID (UNII: 2V16EO95H1) LAURYL ALCOHOL (UNII: 178A96NLP2) EDETATE DISODIUM (UNII: 7FLD91C86K) PIPERONAL (UNII: KE109YAK00) MYRISTYL ALCOHOL (UNII: V42034O9PU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 1200 MPA.S AT 1%) (UNII: 4J4P6L645M) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) DOCOSANOL (UNII: 9G1OE216XY) VANILLIN (UNII: CHI530446X) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LINSEED OIL (UNII: 84XB4DV00W) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-045-72 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2018 Labeler - COOLA, LLC (956990290)