Label: HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 63940-081-94
- 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 January 5, 2022
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- 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.
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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
- Other information
-
Inactive Ingredients
acrylates/dimethicone copolymer, bisabolol, butylene glycol, C12-15 alkyl benzoate, capryloyl glycine, caprylyl glycol, cedrus atlantica bark extract, cetyl dimethicone, chlorphenesin, cinnamomum zeylanicum bark extract, dimethicone, disodium EDTA, ethylhexyl stearate, ethylhexylglycerin, glycerin, mannan, neopentyl glycol diheptanoate, phenoxyethanol, polyester-7, portulaca oleracea extract, sarcosine, silica, sodium polyacrylate, steareth-100, steareth-2, styrene/acrylates copolymer, tocopherol, trideceth-6, water, xanthan gum
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 27 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 40 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 45 mg in 1 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF) CETYL DIMETHICONE 45 (UNII: IK315POC44) CHLORPHENESIN (UNII: I670DAL4SZ) CINNAMON BARK OIL (UNII: XE54U569EC) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) KONJAC MANNAN (UNII: 36W3E5TAMG) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYESTER-7 (UNII: 0841698D2F) PURSLANE (UNII: M6S840WXG5) SARCOSINE (UNII: Z711V88R5F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) STEARETH-100 (UNII: 4OH5W9UM87) STEARETH-2 (UNII: V56DFE46J5) TRIDECETH-6 (UNII: 3T5PCR2H0C) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) HEXYLENE GLYCOL (UNII: KEH0A3F75J) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FARNESOL (UNII: EB41QIU6JL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63940-081-94 177 mL in 1 TUBE; Type 0: Not a Combination Product 01/11/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/11/2021 Labeler - Harmon Stores Inc. (804085293)