Label: COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 79753-023-01
- 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 January 2, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- FLAMMABLE:
- Do not use
- When using this product
- Stop use and ask doctor if
- Keep out of reach of children.
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Directions
• spray liberally and spread evenly 15 minutes before sun exposure
• hold can 4-6 inches away fromskin to apply
• do not spray into face. Spray into hand and apply to face.- Do not apply in windy conditions
• use in well ventilated, but not windy areas
reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours- children under 6 months: 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
SD Alcohol 40-B, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Octylacrylamide Copolymer, Diisopropyl Sebacate, Lauryl Lactate, Fragrance (Natural Fragrance), Caprylic/Capric Triglyceride, Glycerin, Rubus Idaeus (Red Raspberry) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil
- Label
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INGREDIENTS AND APPEARANCE
COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-023 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) ALCOHOL (UNII: 3K9958V90M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) RASPBERRY SEED OIL (UNII: 9S8867952A) LAURYL LACTATE (UNII: G5SU0BFK7O) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) GRAPE SEED OIL (UNII: 930MLC8XGG) CARROT SEED OIL (UNII: 595AO13F11) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-023-01 170 g in 1 CAN; Type 0: Not a Combination Product 09/23/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/23/2021 Labeler - COOLA, LLC (956990290)