FACE VALUES RADIANT FACIAL DAILY MOISTURIZER SPF 15 SUNSCREEN- avobenzone, octinoxate, octisalate 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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FACE VALUES RADIANT FACIAL DAILY MOISTURIZER SPF 15 SUNSCREEN

Active ingredients

Avobnezone 3.0%, Octinoxate 7.5%, Octisalate 2.0%

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

   • 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, C12-15 alkyl benzoate, glycerin, cetearyl alcohol, dimethicone, glycine soja (soybean) seed extract, bis-phenylpropyl dimethicone, arachidyl alcohol, phenoxyethanol, cetearyl glucoside, panthenol, benzyl alcohol, ethylene/acrylic acid copolymer, behenyl alcohol, steareth-2, fragrance, steareth-21, polyacrylamide, polymethyl methacrylate, arachidyl glucoside, disodium EDTA, methylparaben, C13-14 isoparaffin, ethylparaben, butylparaben, laureth-7, benzalkonium chloride, propylparaben, isobutylparaben, iodopropynyl butylcarbamate, BHT, PEG-4 dilaurate, PEG-4 laurate, PEG-4, silica, mica, titanium dioxide.

Questions or comments?

Call toll free 1-800-527-7731

FACE VALUES RADIANT FACIAL DAILY MOISTURIZER SPF 15 SUNSCREEN

4 FL OZ (118.3mL)

NDC 63940-066-04

Label

FACE VALUES RADIANT FACIAL DAILY MOISTURIZER SPF 15 SUNSCREEN

4 FL OZ (118.3mL)/ Blister Carton

NDC 63940-066-05

Blister Pack

FACE VALUES RADIANT FACIAL DAILY MOISTURIZER SPF 15 SUNSCREEN 
avobenzone, octinoxate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-066
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SOYBEAN (UNII: L7HT8F1ZOD)  
BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
PANTHENOL (UNII: WV9CM0O67Z)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
DOCOSANOL (UNII: 9G1OE216XY)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
LAURETH-7 (UNII: Z95S6G8201)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PEG-4 DILAURATE (UNII: KCR71CW036)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-066-051 in 1 CARTON10/27/2010
1NDC:63940-066-04118.3 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/27/2010
Labeler - HARMON STORES, INC. (804085293)
Registrant - FRUIT OF THE EARTH, INC. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
FRUIT OF THE EARTH, INC.008193513manufacture(63940-066)

Revised: 3/2020
Document Id: a9ac126e-960a-49a6-baee-1811c01ba7a8
Set id: dd44b6b8-c287-40f9-b8c6-39cae6173096
Version: 1
Effective Time: 20200324
 
HARMON STORES, INC.