Label: FACE VALUES ULTRA LIGHT DRY TO THE TOUCH SUNSCREEN BROAD SPECTRUM SPF 55- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 63940-079-94
- 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 July 2, 2021
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- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- 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- children under 6 months: 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 -
Inactive ingredients
water, butyloctyl salicylate, tridecyl salicylate, styrene/acrylates copolymer, silica, VP/hexadecene copolymer, behenyl alcohol, glyceryl stearate, PEG-100 stearate, phenoxyethanol, dimethicone, tocopheryl acetate, ethylhexylglycerin, caprylyl methicone, ethylhexyl stearate, trideceth-6, trimethylsiloxysilicate, sodium polyacrylate, xanthan gum, disodium EDTA, fragrance
- Other information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE VALUES ULTRA LIGHT DRY TO THE TOUCH SUNSCREEN BROAD SPECTRUM SPF 55
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-079 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) TRIDECETH-6 (UNII: 3T5PCR2H0C) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) XANTHAN GUM (UNII: TTV12P4NEE) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) DOCOSANOL (UNII: 9G1OE216XY) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63940-079-94 177 mL in 1 TUBE; Type 0: Not a Combination Product 08/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/29/2019 Labeler - HARMON STORES, INC. (804085293)