Label: MATTE TINTED SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 84248-026-01
- Packager: CLINICAL SKIN LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 11, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Use
- Warnings
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Directions
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating
• 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 from10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor
- Other Information
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Inactive ingredients
Aloe Barbadensis (Aloe Vera) Leaf Extract, Alumina, Aqua (Water), Ascorbic Acid, Bioflavonoids, Brassica Oleracea Italica (Broccoli) Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NG, Ceramide NP, Cetearyl Alcohol, Cetearyl Glucoside, Cholesterol, Dicaprylyl Carbonate, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Iron Oxides (CI 77491, CI77492, CI 77499), Lauryl Glucoside, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Niacinamide, Phenoxyethanol, Phytosphingosine, Polyglyceryl-2 Dipolyhydroxystearate, Polyhydroxystearic Acid, Propanediol, Silica, Sodium C14-16 Olefin Sulfonate, Sodium Lauroyl Lactylate, Sodium Stearoyl Glutamate, Stearic Acid, Superoxide Dismutase, Tocopherol, Trie- thoxycaprylylsilane, Xanthan Gum
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INGREDIENTS AND APPEARANCE
MATTE TINTED SUNSCREEN SPF 50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84248-026 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.8 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength CERAMIDE NG (UNII: C04977SRJ5) PROPANEDIOL (UNII: 5965N8W85T) ALUMINUM OXIDE (UNII: LMI26O6933) CHOLESTEROL (UNII: 97C5T2UQ7J) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) MUSKMELON (UNII: ZV095H5633) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BROCCOLI SEED OIL (UNII: SY01LVD4G4) CERAMIDE AP (UNII: F1X8L2B00J) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) FERRIC OXIDE RED (UNII: 1K09F3G675) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CERAMIDE NP (UNII: 4370DF050B) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) NIACINAMIDE (UNII: 25X51I8RD4) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHICONE (UNII: 92RU3N3Y1O) ASCORBIC ACID (UNII: PQ6CK8PD0R) GLYCERIN (UNII: PDC6A3C0OX) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84248-026-01 1 in 1 CARTON 06/17/2024 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/17/2024 Labeler - CLINICAL SKIN LLC (106954468) Registrant - CLINICAL SKIN LLC (106954468)
