LOREAL PARIS INFALLIBLE LONGWEAR SHAPING STICK FOUNDATION SPF 27- octinoxate cream

Loreal Paris Infallible Longwear Shaping Stick Foundation SPF 27 by

Drug Labeling and Warnings

Loreal Paris Infallible Longwear Shaping Stick Foundation SPF 27 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 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:
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant suncreen 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 shrits, pants, hat 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, octyldodecyl neoentaroate, phenyl trimethicone, dicaprylyl carbonate, hydrogenated jojoba oil, nylon-12, hydrogenated polyisobutene, silica dimethyl silylate, polyethylene, talc, disodium stearoyl glutamate, aluminum hydroxide, tocopheryl acetate, BHT, tocopherol; may contain: titanium dioxide, iron oxides, mica

Questions or comments?

1-800-322-2036
Monday-Friday
(10 a.m.-5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS INFALLIBLE LONGWEAR SHAPING STICK FOUNDATION SPF 27 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)
NYLON-12 (UNII: 446U8J075B)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TALC (UNII: 7SEV7J4R1U)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-025-01	9 g in 1 CASE; Type 0: Not a Combination Product	10/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(49967-025) , pack(49967-025)