HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
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 BREAK-OUT FREE SPF 55 SUNSCREEN LOTION

Active Ingredients

Avobenzone 2.7%,

Homosalate 4.0%,

Octisalate 4.5%,

Octocrylene 6.0%,

Oxybenzone 4.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn

• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

• on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash occurs

Keep out of reach of children.

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

Directions

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months: Ask a doctor

• 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

42344A1

HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-081
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE40 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE45 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-081-94177 mL in 1 TUBE; Type 0: Not a Combination Product01/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/11/2021
Labeler - Harmon Stores Inc. (804085293)

Revised: 1/2022
Document Id: d4deca05-bc87-d760-e053-2a95a90a17f8
Set id: d4de2243-6ff8-1d9b-e053-2a95a90a1345
Version: 3
Effective Time: 20220105
 
Harmon Stores Inc.