MAYBELLINE NEW YORK MASTER PRIME BY FACE STUDIO PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate lotion

Maybelline New York Master Prime By Face Studio Primer Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Maybelline New York Master Prime By Face Studio Primer 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

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:
● 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, cyclohexasiloxane, propylene glycol, glycerin, octyldodecanol, stearic acid, potassium cetyl phosphate, palmitic acid, PEG-100 stearate, glyceryl stearate, triethanolamine, phenoxyethanol, cetyl alcohol, talc, dimethicone, silica, methylparaben, caprylyl glycol, carbomer, fragrance, ethylparaben, capryloyl salicylic acid, xanthan gum, disodium EDTA, butylphenyl methylpropional, hexyl cinnamal, linalool, sodium palmitoyl proline, limonene, benzyl salicylate, benzyl alcohol, citronellol, hydroxycitronellal, prunus cerasus (bitter cherry) extract, rosa centifolia flower extract, nymphaea alba flower extract; may contain: mica, titanium dioxide, bismuth oxychloride, iron oxides, red 4, yellow 5

Questions or comments?

1-800-944-0730

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAYBELLINE NEW YORK MASTER PRIME BY FACE STUDIO PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-196
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

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 STEARATE SE (UNII: FCZ5MH785I)
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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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: 49967-196-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/31/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/31/2014

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L’Oreal USA, Inc.		624244349	manufacture(49967-196)