LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN LIGHTWEIGHT FLAWLESS COVERAGE OCHRE- octinoxate, octisalate cream

laura mercier tinted moisturizer Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage OCHRE by

Drug Labeling and Warnings

laura mercier tinted moisturizer Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage OCHRE by is a Otc medication manufactured, distributed, or labeled by Gurwitch Products, LLC, Gotha Cosmetics SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

laura mercier tinted moisturizer oil free Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage OCHRE

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 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
  • 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 values 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, Isopropyl Titanium Triisostearate, Dipotassium Glycyrrhizate.

May Contain: Titanium Dioxide, Iron Oxides.

Questions or comments?

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

laura mercier tinted moisturizer oil free Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage OCHRE 50ml (

65342-0003-0)

INGREDIENTS AND APPEARANCE

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN LIGHTWEIGHT FLAWLESS COVERAGE OCHRE 
octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
SIMMONDSIA CHINENSIS WHOLE (UNII: DFM16KFA82)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
SQUALANE (UNII: GW89575KF9)
METHICONE (20 CST) (UNII: 6777U11MKT)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LAURYL PCA (UNII: 29C5O2BJYA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-0003-0	50 mL in 1 TUBE; Type 0: Not a Combination Product	02/06/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/06/2013

Labeler - Gurwitch Products, LLC (884875246)

Establishment
Name	Address	ID/FEI	Business Operations
Gotha Cosmetics SRL		378071679	manufacture(65342-0003)