LAURA MERCIER TINTED MOISTURIZER - ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN - BARE RADIANCE- avobenzone, octinoxate cream

Laura Mercier Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Bare Radiance by

Drug Labeling and Warnings

Laura Mercier Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Bare Radiance by is a Otc medication manufactured, distributed, or labeled by Gurwitch Products, L.L.C., Atlantis Laboratories, Inc., Beauty Manufacturing Solutions Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Avobenzone (2.0%), Octinoxate (7.5%)

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
• 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, dimethicone, mica, cetearyl alcohol, hydrogenated polyisobutene, xylitylglucoside, PEG-40 castor oil, polyglyceryl-4 isostearate, cyclopentasiloxane, potassium cetyl phosphate, hexyl laurate, anhydroxylitol, tocopheryl acetate, cetyl PEG/PPG-10/1 dimethicone, xylitol, polysorbate 60, phenoxyethanol, butylene glycol, tribhenin, sodium dehydroacetate, sodium hyaluronate, allantoin, camellia sinensis leaf extract, copper gluconate, carbomer, hydrogenated olive oil, butyrospermum parkii (shea) butter, aminomethyl propanol, tetrasodium edta, magnesium aluminum silicate, sodium ascorbate, dipotassium glcyrrhizate, tin oxide, may contain: titanium dioxide, iron oixides.

Questions or comments?

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

Product Labels

INGREDIENTS AND APPEARANCE

LAURA MERCIER TINTED MOISTURIZER - ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN - BARE RADIANCE 
avobenzone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-1396
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XYLITOL (UNII: VCQ006KQ1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COPPER GLUCONATE (UNII: RV823G6G67)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
SHEANUT OIL (UNII: O88E196QRF)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
EDETATE SODIUM (UNII: MP1J8420LU)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM ASCORBATE (UNII: S033EH8359)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-1396-0	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	11/29/2010

Labeler - Gurwitch Products, L.L.C. (884875246)

Establishment
Name	Address	ID/FEI	Business Operations
Atlantis Laboratories, Inc.		194673984	manufacture(65342-1396)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	pack(65342-1396)