Kiehls Since 1851 Dermatologist Solutions Skin Tone Correcting and Beautifying BB Sunscreen: Package Insert and Label Information

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SKIN TONE CORRECTING AND BEAUTIFYING BB SUNSCREEN- homosalate, octisalate, octocrylene and titanium dioxide cream
L’Oreal USA Products 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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 50 mg in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 45 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
ALCOHOL
NYLON-12
DISTEARDIMONIUM HECTORITE
TRIBEHENIN
SODIUM CHLORIDE
PEG-30 DIPOLYHYDROXYSTEARATE
PHENOXYETHANOL
DISODIUM STEAROYL GLUTAMATE
ADENOSINE
ALUMINUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-445-01 1 TUBE in 1 CARTON contains a TUBE
1 40 mL in 1 TUBE This package is contained within the CARTON (49967-445-01)
2 NDC:49967-445-02 3 mL in 1 PACKET None
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 Operations
Dimensional Merchandising Inc. 076693183 manufacture (49967-445)
Establishment
Name Address ID/FEI Operations
L’Oreal USA, Inc. 185931458 manufacture (49967-445)

Revised: 01/2020 L’Oreal USA Products Inc

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