LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR BB BLUR BROAD SPECTRUM SPF 20 SUNSCREEN- titanium dioxide cream

La Roche Posay Laboratoire Dermatologique Effaclar BB Blur Broad Spectrum SPF 20 Sunscreen by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Effaclar BB Blur Broad Spectrum SPF 20 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, BCM Cosmetique SAS, Cosmetique Active Production, Socoplan. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Titanium dioxide 10.66%

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 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

dimethicone, undecane, dimethicone crosspolymer, tridecane, tocopheryl acetate, silica silylate, perlite, disodium stearoyl glutamate, retinyl  linoleate, aluminum hydroxide; may contain: iron oxides, titanium dioxide

Questions or comments?

1-888-LRP LABO/1-888-577-5226

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR BB BLUR BROAD SPECTRUM SPF 20 SUNSCREEN 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	106.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
UNDECANE (UNII: JV0QT00NUE)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
TRIDECANE (UNII: A3LZF0L939)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PERLITE (UNII: 0SG101ZGK9)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
RETINYL LINOLEATE (UNII: 61911N8D6W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-022-01	1 in 1 CARTON	08/20/2015
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-022-02	1 mL in 1 PACKET; Type 0: Not a Combination Product	08/20/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/20/2015

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
BCM Cosmetique SAS		275359578	manufacture(49967-022) , analysis(49967-022) , pack(49967-022)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetique Active Production		282658798	analysis(49967-022) , manufacture(49967-022)

Establishment
Name	Address	ID/FEI	Business Operations
Socoplan		276221405	pack(49967-022)