Label: COOLA BARE REPUBLIC CLEARSCREEN SPF100- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 79753-021-01
- 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 January 2, 2023
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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
Water, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Dimethicone Copolymer, Behenyl Alcohol, Diisopropyl Sebacate, Lauryl Lactate, Glyceryl Behenatae,Vitis Vinifera (Grape) Seed Extract, Daucus Carota Sativa (Carrot) Extract, Rubus Idaeus (Raspberry) Seed Extract, Sodium Hyaluronate, Glycerin, Ethylhexylglycerin, Chlorphenesin, Polyurethane-62, Silica, Ammonium Acryloyldimethyltaurate/VP Copolymer, Trideceth-6, Tocopherol, Arachidyl Alcohol, Arachidyl Glucoside, Lecithin, Sodium Phytate
- Label
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INGREDIENTS AND APPEARANCE
COOLA BARE REPUBLIC CLEARSCREEN SPF100
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) RASPBERRY SEED OIL (UNII: 9S8867952A) CHLORPHENESIN (UNII: I670DAL4SZ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CARROT SEED OIL (UNII: 595AO13F11) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) GRAPE SEED OIL (UNII: 930MLC8XGG) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) DOCOSANOL (UNII: 9G1OE216XY) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) PHYTATE SODIUM (UNII: 88496G1ERL) POLYURETHANE-62 (UNII: TBK645J3J8) LAURYL LACTATE (UNII: G5SU0BFK7O) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M) TRIDECETH-6 (UNII: 3T5PCR2H0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-021-01 59 mL in 1 TUBE; Type 0: Not a Combination Product 10/21/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/21/2021 Labeler - COOLA, LLC (956990290)