Label: FACE VALUES WET N DRY WET SKIN SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 63940-085-10
- Packager: HARMON STORES, INC.
- 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 22, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- FLAMMABLE:
- 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
- Spray liberally and spread evenly by hand 15 minutes before sun exposure
- Hold can 4-6 inches away from skin to apply
- Do not spray into face. Spray into hand and apply to face.
- Use in well ventilated area
- reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• 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
alcohol denat., cyclopentasiloxane, tridecyl salicylate, octyldodecyl citrate crosspolymer, trimethylpentanediol/adipic acid/glycerin crosspolymer, ethyl methicone, bis-hydroxyethoxypropyl dimethicone, acrylates/dimethicone copolymer, fragrance, tocopheryl acetate, nelumbo nucifera flower extract, ascorbyl palmitate, propylene glcol
- Label
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INGREDIENTS AND APPEARANCE
FACE VALUES WET N DRY WET SKIN SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-085 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M) ALCOHOL (UNII: 3K9958V90M) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M) TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q) ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST) (UNII: YP714N2H05) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV) ASCORBYL PALMITATE (UNII: QN83US2B0N) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63940-085-10 283 g in 1 CAN; Type 0: Not a Combination Product 07/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/02/2021 Labeler - HARMON STORES, INC. (804085293)
