Label: CVS HEALTH OIL FREE BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate stick
- NDC Code(s): 51316-039-01
- 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 March 24, 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 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 - Other information
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Inactive ingredients
paraffin, C12-15 alkyl benzoate, tridecyl salicylate, ozokerite, euphorbia cerifera (candililla) wax, neopentyl glycol diethylhexanoate, neopentyl glycol diisostearte, dimethicone, ascorbyl palmitate, tocopheryl acetate, polysilicone-11, cetyl alcohol, beeswax, polyethylene, ethylhexyl methoxycrylene, caprylyl glycol, cyclopentasiloxane, fragrance
- Label
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INGREDIENTS AND APPEARANCE
CVS HEALTH OIL FREE BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-039 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CERESIN (UNII: Q1LS2UJO3A) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) PARAFFIN (UNII: I9O0E3H2ZE) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) CANDELILLA WAX (UNII: WL0328HX19) NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW) WHITE WAX (UNII: 7G1J5DA97F) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-039-01 1 in 1 BLISTER PACK 10/31/2018 1 13.3 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/31/2018 Labeler - CVS Pharmacy (062312574)