Kiehls Since 1851 Broad Spectrum SPF 30 Sunscreen Powerful Wrinkle Reducing: Package Insert and Label Information

KIEHLS SINCE 1851 BROAD SPECTRUM SPF 30 SUNSCREEN POWERFUL WRINKLE REDUCING- avobenzone, homosalate, octisalate and octocrylene 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

Avobenzone 3%

Homosalate 2.7%

Octisalate 5%

Octocrylene 7%

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, cetearyl alcohol, isohexadecane, glyceryl stearate, cyclohexasiloxane, isononyl isononanoate, butyrospermum parkii (shea) butter, PEG-100 stearate, ceteareth-20, phenoxyethanol, butylene glycol, ammonium polyacryloyldimethyl taurate, caprylyl glycol, tocopherol, chlorphenesin, xanthan gum, disodium EDTA, p-anisic acid, calcium PCA, adenosine, copper PCA, alteromonas ferment extract, corallina officinalis extract, citric acid, sodium hydroxide

Questions or comments?

Call toll free 1-800-946-4453

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KIEHLS SINCE 1851 BROAD SPECTRUM SPF 30 SUNSCREEN POWERFUL WRINKLE REDUCING
avobenzone, homosalate, octisalate and octocrylene cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-501
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 27 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 70 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
ISOHEXADECANE
ISONONYL ISONONANOATE
PEG-100 STEARATE
PHENOXYETHANOL
BUTYLENE GLYCOL
CAPRYLYL GLYCOL
TOCOPHEROL
CHLORPHENESIN
XANTHAN GUM
p-ANISIC ACID
ADENOSINE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-501-01 50 mL in 1 JAR None
2 NDC:49967-501-02 75 mL in 1 JAR None
3 NDC:49967-501-03 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 12/01/2012
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
L’Oreal USA, Inc. 185931458 manufacture (49967-501)

Revised: 01/2020 L’Oreal USA Products Inc

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