Label: COOLA BARE REPUBLIC CLEARSCREEN SPF50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 79753-014-71
- 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
Behenyl Alcohol, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Gluoside, Cetearyl Olivate, Cetyl Palmitate, Chlorophenesin, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium Hyaluronate, Sodium Hydroxide, Sodium Phytate, Sorbitan Olivate, Sorbitan Palmitate, 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 SPF50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength CETYL PALMITATE (UNII: 5ZA2S6B08X) WATER (UNII: 059QF0KO0R) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) CETYL ALCOHOL (UNII: 936JST6JCN) RASPBERRY SEED OIL (UNII: 9S8867952A) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETEARYL OLIVATE (UNII: 58B69Q84JO) BENZYL ALCOHOL (UNII: LKG8494WBH) CHLORPHENESIN (UNII: I670DAL4SZ) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) GLYCERIN (UNII: PDC6A3C0OX) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-014-71 148 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)