LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 SUNSCREEN- octinoxate and titanium dioxide cream

Laura Mercier Flawless Skin Daily Face Shield by

Drug Labeling and Warnings

Laura Mercier Flawless Skin Daily Face Shield by is a Otc medication manufactured, distributed, or labeled by Laura Mercier Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 7.5%	Sunscreen
Titanium Dioxide 5.0%	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
  • 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

Cyclopentasiloxane, Water, Butylene Glycol, PEG-10 Dimethicone, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Methicone, Dipropylene Glycol, Alumina, Glycerin, Panthenol, Sodium Chloride, Phenoxyethanol, Caprylyl Glycol, Polyacrylate-15, Disteardimonium Hectorite, Methicone, Tocopheryl Acetate, Polyacrylate-17, Dipotassium Glycyrrhizate, Disodium EDTA, C11-15 Pareth-40, C11-15 Pareth-7, Silica, Isoceteth-10, Acanthopanax Senticosus (Eleuthero) Root Extract, Rhaponticum Carthamoides Root Extract, Rhodiola Rosea Root Extract, Disodium Lauryl Sulfosuccinate, Sodium Laureth-12 Sulfate, Sodium Benzoate.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

laura mercier

flawless skin

DAILY FACE SHIELD
BROAD SPECTRUM SPF 40
SUNSCREEN

30 mL/1 FL. OZ. LIQ.

INGREDIENTS AND APPEARANCE

LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD   SPF 40 SUNSCREEN
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
C11-15 PARETH-40 (UNII: L774F88277)
C11-15 PARETH-7 (UNII: 261HPE0IS3)
ISOCETETH-10 (UNII: 1K92T9919H)
ELEUTHERO (UNII: ZQH6VH092Z)
RHAPONTICUM CARTHAMOIDES ROOT (UNII: P8CUH2KYHL)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)
SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-413-60	1 in 1 CARTON	04/21/2011
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/21/2011

Labeler - Laura Mercier Cosmetics (193691821)