HARMON FACE VALUES ULTRA LIGHT DRY TO THE TOUCH SPF 30 SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, 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 ULTRA LIGHT DRY TO THE TOUCH SPF 30 SUNSCREEN LOTION

Active ingredients

Avobnezone 2.0%, Homosalate 7.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 3.0%

Purpose

Sunscreen

Uses

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 product is 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

   • children under 6 months: ask a doctor

   • limit time in the sun, especially from 10 a.m.-2 p.m.

   • wear long-sleeve shirts, pants, hats, and sunglasses

Other information

Inactive ingredients

water, silica, adipic acid/diethylene glycol/glycerin crosspolymer, VP/hexadecene copolymer, glycerin, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, avena sativa (oat) kernel extract, squalane, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, BHT, cetyl dimethicone bisabolol, dipotassium glycyrrhizate, glyceryl stearate, PEG-100 stearate, polysorbate 60, tetrasodium EDTA, butylene glycol, trimethylsiloxysilicate, xanthan gum, benzyl alcohol, isopropylparaben, isobutylparaben, butylparaben, phenoxyethanol, fragrance

Questions or comments?

1-800-527-7731

HARMON FACE VALUES ULTRA LIGHT DRY TO THE TOUCH SPF 30 SUNSCREEN LOTION

3 FL OZ (88mL)

NDC 63940-065-09

Label

HARMON FACE VALUES ULTRA LIGHT DRY TO THE TOUCH SPF 30 SUNSCREEN 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE70 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
HEXADECYL POVIDONE (UNII: AG75W62QYU)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
OAT (UNII: Z6J799EAJK)  
SQUALANE (UNII: GW89575KF9)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
VITAMIN A (UNII: 81G40H8B0T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL DIMETHICONE 45 (UNII: IK315POC44)  
LEVOMENOL (UNII: 24WE03BX2T)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
xanthan gum (UNII: TTV12P4NEE)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-065-0988 mL in 1 TUBE; Type 0: Not a Combination Product07/05/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/05/2011
Labeler - HARMON STORES, INC. (804085293)
Registrant - FRUIT OF THE EARTH, INC. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
FRUIT OF THE EARTH, INC.008193513manufacture(63940-065)

Revised: 3/2020
Document Id: d51f311d-52db-451a-9303-aa0560ced942
Set id: 1b744adf-634c-4e47-8982-84120de2db80
Version: 1
Effective Time: 20200324
 
HARMON STORES, INC.