HARMON FACE VALUES REFRESHING COOLING BODY MIST SUNSCREEN SPF 45- avobenzone, homosalate, octisalate, octocrylene aerosol, spray 
HARMON STORES, INC.

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.

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HARMON FACE VALUES REFRESHING COOLING BODY MIST SUNSCREEN SPF 45 CONTINUOUS SPRAY

Active ingredients

Avobenzone 3.0%, Homosalate, 15.0%, Octisalate 5.0%, Octocrylene 2.35%

Purpose

Sunscreen

Uses

Warnings

For external use only

FLAMMABLE:

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

Stop use and ask a doctor if

• rash occurs.

Keep out of reach of children.Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

   • after 80 minutes of swimming or sweating

   • immediately after towel drying

   • at least every 2 hours

   • 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

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

42074D6

HARMON FACE VALUES REFRESHING COOLING BODY MIST SUNSCREEN SPF 45 
avobenzone, homosalate, octisalate, octocrylene aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-086
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE23.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-086-88226 g in 1 CAN; Type 0: Not a Combination Product04/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/17/2020
Labeler - HARMON STORES, INC. (804085293)

Revised: 12/2022
Document Id: f0f0ebb0-132f-8517-e053-2a95a90a89d5
Set id: f0f0e4cd-3148-4c1a-e053-2995a90a64eb
Version: 1
Effective Time: 20221228
 
HARMON STORES, INC.