LAURA MERCIER TINTED MOISTURIZER SPF 20 Almond: Package Insert and Label Information

LAURA MERCIER TINTED MOISTURIZER SPF 20 ALMOND- octinoxate and octisalate cream
Gurwitch Products

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.

Drug Facts

Active Ingredients

Octinoxate (5.5%), Octisalate (3.0%)

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 put 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
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• 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, Disiloxane, PEG-30 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Ethylhexyl Palmitate, Glycerin, Isohexadecane, Cyclopentasiloxane, Phenoxyethanol, Boron Nitride, Jojoba Esters, Magnesium Stearate, Sodium Dehydroacetate, Squalane, Methicone, Disodium EDTA, Methylparaben, Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate, Propylparaben, Lauryl PCA, Tocopheryl Acetate, PPG-15 Stearyl Ether, Dipotassium Glycyrrhizate, Isopropyl Titanium Triisostearate. May Contain: Titanium Dioxide, Iron Oxides.

Questions or comments?

Call 1-888-637-2437, M — F 9am — 5pm CST.

Package Labeling:

LAURA MERCIER TINTED MOISTURIZER SPF 20 ALMOND octinoxate, octisalate cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65342-2010 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (OCTINOXATE) OCTINOXATE 55 mg in 1 mL OCTISALATE (OCTISALATE) OCTISALATE 30 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER HEXAMETHYLDISILOXANE PEG-30 DIPOLYHYDROXYSTEARATE ALKYL (C12-15) BENZOATE ETHYLHEXYL PALMITATE GLYCERIN ISOHEXADECANE CYCLOMETHICONE 5 PHENOXYETHANOL BORON NITRIDE HYDROLYZED JOJOBA ESTERS (ACID FORM) MAGNESIUM STEARATE SODIUM DEHYDROACETATE SQUALANE METHICONE (20 CST) EDETATE DISODIUM METHYLPARABEN PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PROPYLPARABEN LAURYL PCA .ALPHA.-TOCOPHEROL ACETATE PPG-15 STEARYL ETHER GLYCYRRHIZINATE DIPOTASSIUM ISOPROPYL TITANIUM TRIISOSTEARATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65342-2010-1 1 TUBE in 1 CARTON contains a TUBE 1 50 mL in 1 TUBE This package is contained within the CARTON (65342-2010-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/14/2017 12/31/2023

Labeler — Gurwitch Products (884875246)

Revised: 02/2021 Gurwitch Products