Label: PLAY MINERAL SUNSCREEN SPF-50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 73088-101-14
- Packager: TUBBY TODD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2024
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
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DIRECTIONS
• Apply generously 15 minutes before sun exposure and as needed.
• reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating.
• 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. [bullet] wear long-sleeved shirts, pants, hats, and sunglasses". - OTHER INFORMATION
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INACTIVE INGREDIENT
Alkyl Benzoate, Benzoic Acid, C12-C15, Caprylic Capric Triglycerides, Cetyl PEG/PPG-10/1 Dimethicone, Crosspolymer, Dicaprylyl ether, Ethylhexylglycerin, Glycereth-2 Cocoate, Glycerin, Isostearic Acid, Octyldodecyl Stearoyl Citrate, Phenoxyethanol, Polyhydroxystearic Acid, Propanediol, Sodium Chloride, Sodium Hyaluronate, Triethoxycaprylylsilane, Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PLAY MINERAL SUNSCREEN SPF-50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73088-101 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 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 7 g in 100 mL Inactive Ingredients Ingredient Name Strength C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C) BENZOIC ACID (UNII: 8SKN0B0MIM) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) DICAPRYLYL ETHER (UNII: 77JZM5516Z) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERETH-2 COCOATE (UNII: JWM00VS7HC) ISOSTEARIC ACID (UNII: X33R8U0062) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PROPANEDIOL (UNII: 5965N8W85T) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73088-101-14 118 mL in 1 TUBE; Type 0: Not a Combination Product 05/21/2019 12/12/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/21/2019 12/12/2024 Labeler - TUBBY TODD (052545299)