MAYBELLINE NEW YORK SUPERSTAY BETTER SKIN SKIN TRANSFORMING FOUNDATION BROAD SPECTRUM SPF 20 SUNSCREEN- titanium dioxide lotion

Maybelline New York Superstay Better Skin Skin Transforming Foundation Broad Spectrum SPF 20 Sunscreen by

Drug Labeling and Warnings

Maybelline New York Superstay Better Skin Skin Transforming Foundation Broad Spectrum SPF 20 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 1.53%

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:
● shake well

● 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, dimethicone, isododecane, polypropylsilsesquioxane, C30-45 alkyldimethylsilyl polypropylsilsesquioxane, silica, glycerin, PEG-10 dimethicone, disteardimonium hectorite, dimethicone/polyglycerin-3 crosspolymer, sodium chloride, nylon-12, phenoxyethanol, 3-o-ethyl ascorbic acid, caprylyl glycol, panthenol, disodium stearoyl glutamate, sodium dehydroacetate, disodium EDTA, acrylates copolymer, aluminum hydroxide, dipropylene glycol, zinc gluconate, magnesium aspartate, paraffin, copper gluconate, may contain: titanium dioxide, iron oxides

Questions or comments?

1-800-944-0730

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INGREDIENTS AND APPEARANCE

MAYBELLINE NEW YORK SUPERSTAY BETTER SKIN SKIN TRANSFORMING FOUNDATION BROAD SPECTRUM SPF 20 SUNSCREEN 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-837
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPARABEN (UNII: A2I8C7HI9T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ETHYLPARABEN (UNII: 14255EXE39)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
PRUNUS CERASUS FLOWER BUD (UNII: 1MG3D59XD7)
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-837-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/31/2013

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L’Oreal USA, Inc.		624244349	manufacture(49967-837)