KIEHLS SINCE 1851 FACIAL FUEL ENERGIZING MOISTURE TREATMENT FOR MEN BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, octisalate and octocrylene lotion

Kiehls Since 1851 Facial Fuel Energizing Moisture Treatment for Men Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Kiehls Since 1851 Facial Fuel Energizing Moisture Treatment for Men Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%
Octisalate 5%
Octocrylene 5%

Purpose

Sunscreen

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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 value of 15 or higher and other sun protection measures including:

● limit time in the sun, especially from 10 a.m. – 2 p.m.

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

● children under 6 months of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, glycerin, alcohol denat., silica, cyclohexsiloxane, propylene glycol, synthetic fluorphlogopite, cetyl alcohol, dimethicone, stearic acid, palmitic acid, phenoxyethanol, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, fragrance, dimethiconol, zea mays (corn) germ oil, caffeine, tocopherol, disodium EDTA, menthol, limonene, biosacchaide gum-1, sodium hydroxide, ascorbyl glucoside, castanea sativa (chestnut) seed extract, citrus medica limonum (lemon) juice, hydrolyzed soy protein, citrus aurantium dulcis (orange) juice, linalool, citral, red 4, blue 1

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS SINCE 1851 FACIAL FUEL ENERGIZING MOISTURE TREATMENT FOR MEN BROAD SPECTRUM SPF 15 SUNSCREEN 
avobenzone, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-583
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
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARIC ACID (UNII: 4ELV7Z65AP)
PALMITIC ACID (UNII: 2V16EO95H1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CORN OIL (UNII: 8470G57WFM)
CAFFEINE (UNII: 3G6A5W338E)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL (UNII: L7T10EIP3A)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)
LEMON JUICE (UNII: AGN709ANTJ)
ORANGE JUICE (UNII: 5A9KE2L9L3)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-583-01	200 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2013
2	NDC: 49967-583-02	125 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2013
3	NDC: 49967-583-03	75 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2013
4	NDC: 49967-583-04	3 mL in 1 PACKET; Type 0: Not a Combination Product	08/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2013

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products Inc		185931458	manufacture(49967-583)