Label: COOLA BARE REPUBLIC CLEARSCREEN SPF30- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 79753-013-71
- Packager: COOLA, LLC
- Category: HUMAN OTC DRUG LABEL
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 March 5, 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
Behenyl Alcohol, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Gluoside, Cetearyl Olivate, Chlorophenesin, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Polymethyl Methacrylate, Rubus Idaeus (Raspberry) Seed Oil, Sodium Hyaluronate, Sodium Hydroxide, Sodium Phytate, Sorbitan Olivate, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl (Vitamin E), Vitis Vinifera (Grape) Seed Oil, VP/Hexadecene Copolymer, Water, Xanthan Gum
- Label
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INGREDIENTS AND APPEARANCE
COOLA BARE REPUBLIC CLEARSCREEN SPF30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-013 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 15 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) RASPBERRY SEED OIL (UNII: 9S8867952A) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETEARYL OLIVATE (UNII: 58B69Q84JO) CETYL ALCOHOL (UNII: 936JST6JCN) CHLORPHENESIN (UNII: I670DAL4SZ) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CARROT SEED OIL (UNII: 595AO13F11) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) XANTHAN GUM (UNII: TTV12P4NEE) SORBITAN OLIVATE (UNII: MDL271E3GR) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) GRAPE SEED OIL (UNII: 930MLC8XGG) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHYTATE SODIUM (UNII: 88496G1ERL) GLYCERIN (UNII: PDC6A3C0OX) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-013-71 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2021 Labeler - COOLA, LLC (956990290)