Label: MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM- zinc oxide lotion
- NDC Code(s): 68577-163-00
- Packager: COSMAX USA, CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
-
DIRECTIONS
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months of age: ask a doctor
Sun Protection Measures
Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
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INACTIVE INGREDIENT
Water (Aqua), Squalane, Isoamyl Laurate, Butyloctyl Salicylate, Propanediol, Caprylic/Capric Triglyceride, Polyglyceryl-3 Diisostearate, Methylpropanediol, Isopropyl Isostearate, Niacinamide, Sodium Chloride, Polyglyceryl-6 Polyricinoleate, Silica, Sorbitan Sesquiisostearate, Caprae Lac (Goat Milk), Bifida Ferment Lysate, Milk Protein, Eryngium Alpinum (Blue Thistle) Flower Extract, Carthamus Tinctorius (Safflower) Seed Oil, Sambucus Nigra (Elderberry) Flower Extract, Leuconostoc/Radish Root Ferment Filtrate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Hydroxyacetophenone, Mica, 1,2-Hexanediol, Caprylyl Glycol, Lauroyl Lysine, Glycerin, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Lactose May Contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)
- Primary Package- MEDIUM
- Secondary Package- MEDIUM
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INGREDIENTS AND APPEARANCE
MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68577-163 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12.0015 mg in 100 mg Inactive Ingredients Ingredient Name Strength TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SQUALANE (UNII: GW89575KF9) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MILK PROTEIN (UNII: AY96EDV46J) METHYLPROPANEDIOL (UNII: N8F53B3R4R) ERYNGIUM ALPINUM FLOWER (UNII: D381NNL4PD) NIACINAMIDE (UNII: 25X51I8RD4) SODIUM CHLORIDE (UNII: 451W47IQ8X) ISOSTEARIC ACID (UNII: X33R8U0062) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISOAMYL LAURATE (UNII: M1SLX00M3M) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) MICA (UNII: V8A1AW0880) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) LAUROYL LYSINE (UNII: 113171Q70B) CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL (UNII: 65UEH262IS) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) GOAT MILK (UNII: XE5K5I4RP7) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) SILICA (UNII: ETJ7Z6XBU4) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) WATER (UNII: 059QF0KO0R) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) LACTOSE (UNII: J2B2A4N98G) IRON OXIDES (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68577-163-00 1 in 1 CARTON 01/01/2024 1 30 mg 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 01/01/2024 Labeler - COSMAX USA, CORPORATION (010990210) Registrant - COSMAX USA, CORPORATION (010990210) Establishment Name Address ID/FEI Business Operations COSMAX USA, CORPORATION 010990210 manufacture(68577-163)
