LANCOME PARIS BB BIENFAIT TEINTE BEAUTY BALM BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate and titanium dioxide cream

Lancome Paris BB Bienfait Teinte Beauty Balm Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Lancome Paris BB Bienfait Teinte Beauty Balm Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Dimensional Merchandising Inc., L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

Titanium dioxide 5.8%

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 generously and evenly 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, cyclopentasiloxane, cyclohexasiloxane, glycerin, pheny trimethicone, polyglyceryl-4 isostearate, hexyl laurate, cetyl PEG/PPG-10/1 dimethicone, disteardimonium hectorite, pentylene glycol, moringa pterygosperma seed extract, triethanolamine, trihydroxystearin, silica, alumina, aluminum hydroxide, magnesium sulfate, alcohol denat., ascorbyl gluycoside, disodium stearoyl glutamate, acetylated glycol stearate, panthenol, castanea sativa (chestnut) seed extarct, tocopheryl acetate, methylparaben, phenoxyethanol, diazolidinyl urea, linalool, geraniol, alpha-isomethyl ionone, citronellol, benzyl alcohol, benzyl salicylate, fragrance; may contain: titanium dioxide, iron oxides

QUESTIONS

1-800-LANCOME (1-800-526-2663)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANCOME PARIS BB BIENFAIT TEINTE BEAUTY BALM BROAD SPECTRUM SPF 30 SUNSCREEN 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-384
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	58 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-384-01	1 in 1 CARTON	08/01/2013
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	08/01/2013

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc.		076693183	manufacture(49967-384)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-384)