HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN LOTION TWIN PACK

HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN LOTION TWIN PACK

Drug Labeling and Warnings

Drug Details

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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 TWIN PACK

Active Ingredients

Avobenzone 2.7%, Homosalate 4.0%, Octisalate 4.5%, Octocrylene 6.0%, Oxybenzone 4.5%

Purpose

Skin Protectant

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

  • 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 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-sleeve shirts, pants, hats, and sunglasses

Other information

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

acrylates/dimethicone copolymer, BHT, 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, trideceth-6, water, xanthan gum

Questions or comments?

1-800-527-7731

HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN LOTION TWIN PACK

(2x) 3 FL OZ (88mL)

NDC: 63940-051-09

Label

HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63940-051
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
LEVOMENOL (UNII: 24WE03BX2T)  
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)  
YEAST MANNAN (UNII: 91R887N59P)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYESTER-7 (UNII: 0841698D2F)  
PURSLANE (UNII: M6S840WXG5)  
SARCOSINE (UNII: Z711V88R5F)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
STEARETH-100 (UNII: 4OH5W9UM87)  
STEARETH-2 (UNII: V56DFE46J5)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63940-051-102 in 1 PACKAGE02/27/2017
1NDC: 63940-051-0988 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/27/2017
Labeler - Harmon Stores Inc. (804085293)
Registrant - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of the Earth, Inc.008193513manufacture(63940-051)

Revised: 3/2020
 
Harmon Stores Inc.


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