Label: MINERAL SUNSCREEN BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide lotion
- NDC Code(s): 53727-121-01
- Packager: COSMECCA KOREA CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
- Warnings
-
Directions
- Apply liberally and evenly 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if 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 a 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.
- Other Information
-
Inactive Ingredients
WATER (AQUA), DIMETHICONE, C12-15 ALKYL BENZOATE, PROPANEDIOL, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLOCTYL SALICYLATE, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, NIACINAMDE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, OLIVE OIL POLYGLYCERYL-6 ESTERS, POLYSILICONE-11, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, PERSEA GRATISSIMA (AVOCADO) OIL, POLYGLYCERYL-6 PENAOLEATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, STEARIC ACID, ALPHA-GLUCAN OLIGOSACCHARIDE, SILICA, VITIS VINIFERA (GRAPE) SEED OIL, BISABOLOL, CAFFEINE, TRIETHOXYCAPRYLYLSILANE, ALUMINA, POLYMNIA SONCHIFOLIA ROOT JUICE, POLYHYDROXYSTEARIC ACID, MALTODEXTRIN, SODIUM HYALURONATE, PHENOXYETHANOL, LACTOBACILLUS, MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN BROAD SPECTRUM SPF30
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53727-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 34.4 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 48.8 mg in 1 g Inactive Ingredients Ingredient Name Strength LEVOMENOL (UNII: 24WE03BX2T) CAFFEINE (UNII: 3G6A5W338E) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM OXIDE (UNII: LMI26O6933) SMALLANTHUS SONCHIFOLIUS ROOT JUICE (UNII: M9S7HX36CT) MALTODEXTRIN (UNII: 7CVR7L4A2D) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PROPANEDIOL (UNII: 5965N8W85T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) NIACINAMIDE (UNII: 25X51I8RD4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) AVOCADO OIL (UNII: 6VNO72PFC1) POLYGLYCERYL-10 PENTAOLEATE (UNII: BH1TF96DJC) SHEA BUTTER (UNII: K49155WL9Y) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GRAPE SEED OIL (UNII: 930MLC8XGG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53727-121-01 50 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/01/2023 Labeler - COSMECCA KOREA CO., LTD (688830827)
