FACE VALUES ULTRA SPORT ACTIVE SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene 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 ULTRA SPORT ACTIVE SPF 30 SUNSCREEN LOTION

Active ingredients

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 4.5%, Octocrylene 6.0%

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

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

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

Other information

Inactive ingredients

water, glycerin, polyester-7, neopentyl glycol diheptanoate, aluminum starch octenylsuccinate, silica, styrene/acrylates copolymer, phenoxyethanol, isododecane, arachidyl alcohol, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin E), beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance

Label

42302A1

42331E3F3

FACE VALUES ULTRA SPORT ACTIVE SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-067
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 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
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISODODECANE (UNII: A8289P68Y2)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
DOCOSANOL (UNII: 9G1OE216XY)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
WHITE WAX (UNII: 7G1J5DA97F)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
PEG-100 STEARATE (UNII: YD01N1999R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-067-0988.7 mL in 1 TUBE; Type 0: Not a Combination Product03/15/2016
2NDC:63940-067-11237 mL in 1 PACKAGE; Type 0: Not a Combination Product02/29/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/29/2008
Labeler - HARMON STORES, INC. (804085293)

Revised: 12/2022
Document Id: f119e412-c34c-7b9a-e053-2a95a90ac57b
Set id: 48dd695d-08b3-43f6-8694-1999c33710fb
Version: 4
Effective Time: 20221231
 
HARMON STORES, INC.