Label: HARMON FACE VALUES REFRESHING COOLING BODY MIST SUNSCREEN SPF 45- avobenzone, homosalate, octisalate, octocrylene aerosol, spray
- NDC Code(s): 63940-086-88
- 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 28, 2022
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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.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., tridecyl salicylate, diethylhexyl 2,6-naphthalate, acrylates/octylacrylamide copolymer, dimethicone, trisiloxane, PPG-5-ceteth-20, cyclopentasiloxane, propylene glycol, menthyl lactate, ethoxydiglycol, acrylates/dimethicone copolymer, retinyl palmitate, phospholipids, fragrance, tocopheryl acetate, ascorbyl palmitate, water, beta-carotene.
- Label
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INGREDIENTS AND APPEARANCE
HARMON FACE VALUES REFRESHING COOLING BODY MIST SUNSCREEN SPF 45
avobenzone, homosalate, octisalate, octocrylene aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-086 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 150 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 23.5 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) DIMETHICONE (UNII: 92RU3N3Y1O) TRISILOXANE (UNII: 9G1ZW13R0G) PPG-5-CETETH-20 (UNII: 4AAN25P8P4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) WATER (UNII: 059QF0KO0R) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) BETA CAROTENE (UNII: 01YAE03M7J) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63940-086-88 226 g in 1 CAN; Type 0: Not a Combination Product 04/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/17/2020 Labeler - HARMON STORES, INC. (804085293)