MAYBELLINE NEW YORK DREAM FRESH BB BEAUTY BALM SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN- titanium dioxide cream

Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Titanium dioxide 1.15%

Purpose

Sunscreen

Use

helps prevent sunburn

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

● 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, ethylhexyl palmitate, glycerin, octyldodecanol, silica, pentylene glycol, octyldodecyl xyloside, phenoxyethanol, sodium acrylate/sodium acryloyldimethyl taurate copolymer, hydrogenated lecithin, isohexadecane, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-30 dipolyhydroxystearate, sodium dehydroacetate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, caprylyl glycol, disodium EDTA, citric acid, polysorbate 80, potassium sorbate, propylene glycol, methylisothiazolinone, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf extract; may contain: titanium dioxdie, iron oxides

Questions or comments?

1-800-944-0730

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAYBELLINE NEW YORK DREAM FRESH BB BEAUTY BALM SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-264
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-264-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2012

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		624244349	manufacture(49967-264)