Label: CVS HEALTH SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 51316-010-14, 51316-010-40
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 27, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask doctor if
- Keep out of reach of children.
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Directions
• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• 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
• children under 6 months: Ask a doctor -
Inactive ingredients
water, C12-15 alkyl benzoate, tridecyl salicylate, PEG-8, adipic acid/diglycol crosspolymer, cetearyl alcohol, dicetyl phosphate, ceteth-10 phosphate, caprylyl glycol, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E acetate), sodium ascorbyl phosphate (vitamin C phosphate), hydrated silica, phenoxyethanol, potasium cetyl phosphate, propylene glycol, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, triethanolamine, hexylene glycol
- Other information
- Label
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INGREDIENTS AND APPEARANCE
CVS HEALTH SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) TROLAMINE (UNII: 9O3K93S3TK) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-010-14 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2018 2 NDC:51316-010-40 308 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/05/2018 Labeler - CVS Pharmacy (062312574)
