FACE VALUES ULTRA SPORT ACTIVE SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

FACE VALUES ULTRA SPORT ACTIVE SPF 50 SUNSCREEN by

Drug Labeling and Warnings

FACE VALUES ULTRA SPORT ACTIVE SPF 50 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by HARMON STORES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection mesaures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

DO NOT USE

Do not use  on damaged or broken skin

WHEN USING

When using this product  keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if  rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

• 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, espcially from 10 a.m.-2 p.m.

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

• children under 6 months: ask a doctor

Other information

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

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

PRINCIPAL DISPLAY PANEL

FACE VALUES ULTRA SPORT ACTIVE SPF 50 SUNSCREEN LOTION

3 FL OZ (88.7mL)

NDC: 63940-068-09

INGREDIENTS AND APPEARANCE

FACE VALUES ULTRA SPORT ACTIVE SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-068-09	88.7 mL in 1 TUBE; Type 0: Not a Combination Product	04/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/06/2017

Labeler - HARMON STORES, INC. (804085293)

Registrant - FRUIT OF THE EARTH, INC. (008193513)

Establishment
Name	Address	ID/FEI	Business Operations
FRUIT OF THE EARTH, INC.		079559467	manufacture(63940-068)