FACE VALUES ULTRA SPORT ACTIVE SPF 50 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 50 SUNSCREEN LOTION

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

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-sleeve 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

Questions or comments?

1-800-527-7731

FACE VALUES ULTRA SPORT ACTIVE SPF 50 SUNSCREEN LOTION

3 FL OZ (88.7mL)

NDC 63940-068-09

Label

FACE VALUES ULTRA SPORT ACTIVE SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-068
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) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
DOCOSANOL (UNII: 9G1OE216XY)  
TOCOPHEROL (UNII: R0ZB2556P8)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-068-0988.7 mL in 1 TUBE; Type 0: Not a Combination Product04/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/06/2017
Labeler - HARMON STORES, INC. (804085293)
Registrant - FRUIT OF THE EARTH, INC. (008193513)
Establishment
NameAddressID/FEIBusiness Operations
FRUIT OF THE EARTH, INC.079559467manufacture(63940-068)

Revised: 3/2020
Document Id: c04814d1-c286-4afa-ad70-7520d5206ffe
Set id: 09705085-76e4-4ddf-a9f9-cfaa878c7054
Version: 1
Effective Time: 20200330
 
HARMON STORES, INC.