KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SKIN TONE CORRECTING AND BEAUTIFYING BB SUNSCREEN- homosalate, octisalate, octocrylene and titanium dioxide cream

Kiehls Since 1851 Dermatologist Solutions Skin Tone Correcting and Beautifying BB Sunscreen by

Drug Labeling and Warnings

Kiehls Since 1851 Dermatologist Solutions Skin Tone Correcting and Beautifying BB Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Dimensional Merchandising Inc., L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Titanium dioxide 4.5%

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 of 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, dicaprylyl ether, glycerin, alcohol denat., polyglyceryl-4 isostearate, ascorbyl glucoside, silica, nylon-12, disteardimonium hectorite, tirbehenin, PEG-30 dipolyhydroxystearate, sodium chloride, phenoxyethanol, disodium stearoyl glutamate, adenosine, aluminum hydroxide; may contain: titanium dioxide, iron oxides

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SKIN TONE CORRECTING AND BEAUTIFYING BB SUNSCREEN 
homosalate, octisalate, octocrylene and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-445
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
NYLON-12 (UNII: 446U8J075B)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-445-01	1 in 1 CARTON	03/01/2013
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-445-02	3 mL in 1 PACKET; Type 0: Not a Combination Product	03/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2013

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc.		076693183	manufacture(49967-445)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-445)