Label: CVS HEALTH 50 HYDRATING MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion
- NDC Code(s): 51316-046-15
- Packager: CVS PHARMACY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 25, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
- 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 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.
• wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
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Inactive ingredients
WATER, ISOHEXADECANE, BUTYLOCTYL SALICYLATE, CETYL DIMETHICONE, STYRENE/ACRYLATES COPOLYMER, OLIVE OIL POLYGLYCERYL-6 ESTERS, SORBITAN OLIVATE, SODIUM STEAROYL LACTYLATE, VP/EICOSENE COPOLYMER, CETEARYL ALCOHOL, CETEARYL OLIVATE, CETYL PALMITATE, SORBITAN PALMITATE, DIMETHICONE PEG-8 LAURATE, CERAMIDE NP, CERAMIDE AP, CERAMIDE EOP, CHOLESTEROL, PHYTOSPHINGOSINE, HYDROLYZED HYALURONIC ACID, BENZYL ALCOHOL, BISABOLOL, DIPOTASSIUM GLYCYRRHIZATE, PROPANEDIOL, XANTHAN GUM, ALUMINUM HYDROXIDE, SODIUM LAUROYL LACTYLATE, CARBOMER, TOCOPHERYL ACETATE, DISODIUM EDTA, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, CITRIC ACID, PHENOXYETHANOL, CAPRYLOYL GLYCINE, UNDECYLENOYL GLYCINE.
- Label
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INGREDIENTS AND APPEARANCE
CVS HEALTH 50 HYDRATING MINERAL SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-046 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength LEVOMENOL (UNII: 24WE03BX2T) CETYL DIMETHICONE 45 (UNII: IK315POC44) DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18) FARNESOL (UNII: EB41QIU6JL) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CERAMIDE NP (UNII: 4370DF050B) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CERAMIDE AP (UNII: F1X8L2B00J) CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) CETYL PALMITATE (UNII: 5ZA2S6B08X) CHOLESTEROL (UNII: 97C5T2UQ7J) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) UNDECYLENOYL GLYCINE (UNII: 4D20464K2J) SORBITAN OLIVATE (UNII: MDL271E3GR) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) WATER (UNII: 059QF0KO0R) CETEARYL OLIVATE (UNII: 58B69Q84JO) EDETATE DISODIUM (UNII: 7FLD91C86K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) BENZYL ALCOHOL (UNII: LKG8494WBH) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ISOHEXADECANE (UNII: 918X1OUF1E) OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) PROPANEDIOL (UNII: 5965N8W85T) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-046-15 150 mL in 1 TUBE; Type 0: Not a Combination Product 12/09/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/09/2019 Labeler - CVS PHARMACY (062312574)