Label: CORAL ISLE SPF 50 MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion
- NDC Code(s): 72839-114-02, 72839-114-06, 72839-114-12, 72839-114-16
- Packager: Derma Care Research Labs, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 2, 2024
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Keep Out of 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
Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:
- limit time in the sun, especially from 10 am to 2 pm
- wear long-sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months: ask a doctor.
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Inactive Ingredients
Water, ethylhexyl palmitate, C12-15 alkyl benzoate, styrene/acrylates copolymer, glycerin, sorbitan olivate, cetyl PEG/PPG-10/1 dimethicone, dimethicone, aluminum starch octenylsuccinate, sodium chloride, silica, aloe barbadensis leaf extract, cucumis sativus (cucumber) fruit extract, mentha piperita (peppermint) leaf extract, punica granatum fruit juice, oryza sativa (rice) bran water, rosmarinus officinalis (rosemary) leaf extract, vitis vinifera (grade) seed extract, camellia sinensis leaf extract, ethylhexylglycerin, propanediol, disodium EDTA, phenoxyethanol, alumina, hydrogen dimethicone
- Label
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INGREDIENTS AND APPEARANCE
CORAL ISLE SPF 50 MINERAL SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-114 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4 g in 100 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE (UNII: 2865993309) EDETATE DISODIUM (UNII: 7FLD91C86K) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) SORBITAN OLIVATE (UNII: MDL271E3GR) DIMETHICONE 200 (UNII: RGS4T2AS00) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) SODIUM CHLORIDE (UNII: 451W47IQ8X) ROSEMARY (UNII: IJ67X351P9) VITIS VINIFERA SEED (UNII: C34U15ICXA) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALUMINUM OXIDE (UNII: LMI26O6933) ALOE VERA LEAF (UNII: ZY81Z83H0X) MENTHA PIPERITA LEAF (UNII: A389O33LX6) CUCUMBER (UNII: YY7C30VXJT) POMEGRANATE JUICE (UNII: 99S671U9KB) RICE BRAN, DEFATTED (UNII: H6597RO5A2) PROPANEDIOL (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72839-114-06 170 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2024 2 NDC:72839-114-12 57 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2024 3 NDC:72839-114-02 57 g in 1 BOTTLE; Type 0: Not a Combination Product 01/02/2024 4 NDC:72839-114-16 170 g in 1 BOTTLE; Type 0: Not a Combination Product 01/02/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/23/2023 Labeler - Derma Care Research Labs, LLC (116817470) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs 116817470 manufacture(72839-114)
