Label: CVS HEALTH 50 CLEAR ZINC BROAD SPECTRUM SPF 50 SUNSCREEN- octocrylene, zinc oxide lotion
- NDC Code(s): 51316-043-13, 51316-043-85
- 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 24, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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.
-
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
-
Inactive ingredients
WATER, ETHYLHEXYL STEARATE, DIISOPROPYL ADIPATE, CETY DIMETHICONE, CETY PEG/PPG-10/1 DIMETHICONE, HYDROGENATED CASTOR OIL, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, BEESWAX, ISOHEXADECANE, PHENOXYETHANOL, SILICA, ETHYLHEXYLGLYCERIN, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE, SODIUM CHLORIDE, DISODIUM EDTA, ALOE BARBADENSIS LEAF POWDER, SODIUM ASCORBYL PHOSPHATE, TOCOPHEROL,
- Label
-
INGREDIENTS AND APPEARANCE
CVS HEALTH 50 CLEAR ZINC BROAD SPECTRUM SPF 50 SUNSCREEN
octocrylene, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-043 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM CHLORIDE (UNII: 451W47IQ8X) WHITE WAX (UNII: 7G1J5DA97F) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) CETYL DIMETHICONE 45 (UNII: IK315POC44) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYL LAURATE (UNII: 4CG9F9W01Q) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) ISOHEXADECANE (UNII: 918X1OUF1E) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-043-13 118 mL in 1 TUBE; Type 0: Not a Combination Product 10/03/2018 2 NDC:51316-043-85 59 mL in 1 JAR; Type 0: Not a Combination Product 10/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/03/2018 Labeler - CVS PHARMACY (062312574)
