KIEHLS SINCE 1851 FACIAL FUEL DAILY ENERGIZING MOISTURE TREATMENT FOR MEN BROAD SPECTRUM SPF 20 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

Kiehls Since 1851 Facial Fuel Daily Energizing Moisture Treatment for Men Broad Spectrum SPF 20 Sunscreen by

Drug Labeling and Warnings

Kiehls Since 1851 Facial Fuel Daily Energizing Moisture Treatment for Men Broad Spectrum SPF 20 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%

Homosalate 8.8%

Octisalate 4.9%

Octocrylene 5.9%

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., tocopherol, aloe barbadensis leaf juice, phenoxyethanol, sodium hydroxide, caprylyl glycol, sodium polyacrylate, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, ascorbyl glucoside, caffeine, sodium hyaluronate, xanthan gum, menthyl lactate, disodium EDTA, limonene, ceramide NP, castanea sativa (chestnut) seed extract, pentylene glycol, hydrolyzed soy protecin, linalool, citric acid, potassium sorbate, citral, sodium benzoate, ethylhexylglycerin

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS SINCE 1851 FACIAL FUEL DAILY ENERGIZING MOISTURE TREATMENT FOR MEN BROAD SPECTRUM SPF 20 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-608
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	88 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	49 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	59 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
CAFFEINE (UNII: 3G6A5W338E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYL LACTATE, (-)- (UNII: 0379G9C44S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CERAMIDE NP (UNII: 4370DF050B)
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRAL (UNII: T7EU0O9VPP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-608-01	1 in 1 CARTON	03/29/2018
1		125 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-608-02	1 in 1 CARTON	03/29/2018
2		15 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-608-03	1 in 1 CARTON	12/10/2018
3		75 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 49967-608-04	1 in 1 CARTON	12/10/2018
4		200 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/29/2018

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products Inc		185931458	manufacture(49967-608)