Label: COOLA BARE REPUBLIC MINERAL SPORT SPF50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 79753-029-71, 79753-029-72
- Packager: COOLA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 23, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
-
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
-
Inactive Ingredients
Alcohol, AleuritesMoluccana (Kukui) Seed Oil, Algae Exract, Allyl Heptoate, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Gamma Decalactone, Gamma Nonalactone, Gamma Octalactone, Glycerin, Heliotropine, Isohecxadecane, Lauryl PEG-8 Dimethicone, Octyldodecyl Citrate Crosspolymer, PEG-8, Phenylpropenol, Raspberry Ketone, Silica, Sodium Chloride, Sodium Citrate, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethyl Citrate, Vanillin, Vegan Beeswax, Water
- Label
-
INGREDIENTS AND APPEARANCE
COOLA BARE REPUBLIC MINERAL SPORT SPF50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-029 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 78 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 29 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) KUKUI NUT OIL (UNII: TP11QR7B8R) ALLYL HEPTANOATE (UNII: AU4CYG9V68) ISOHEXADECANE (UNII: 918X1OUF1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) COCONUT OIL (UNII: Q9L0O73W7L) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) PIPERONAL (UNII: KE109YAK00) OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M) 3-PHENYL-1-PROPANOL (UNII: U04IC2765C) ALCOHOL (UNII: 3K9958V90M) SODIUM CITRATE (UNII: 1Q73Q2JULR) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK) ALOE VERA LEAF (UNII: ZY81Z83H0X) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) 4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VANILLIN (UNII: CHI530446X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-029-71 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 2 NDC:79753-029-72 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/01/2018 Labeler - COOLA, LLC (956990290)