LOREAL PARIS YOUTH CODE BROAD SPECTRUM SPF 15 BB- octinoxate and titanium dioxide cream

LOreal Paris Youth Code Broad Spectrum SPF 15 BB by

Drug Labeling and Warnings

LOreal Paris Youth Code Broad Spectrum SPF 15 BB 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 ingredients

Octinoxate 4%

Titanium dioxide 3.6%

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

CAUTION: Flammable until dry.

Do not use near fire, flame or heat.

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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, isononyl isononanoate, isohexadecane, glycerin, alcohol denat., PEG-20 methyl glucose sesquistearate, methyl glucose sesquistearate, cetyl palmitate, nylon-12, cyclohexasiloxane, propylene glycol, hydrogenated polyisobutene, stearyl alcohol, magnesium aluminum silicate, phenoxyethanol, caprylyl glycol, lithium magnesium sodium silicate, ethylhexyl hydroxystearate, disodium EDTA, linalool, benzyl salicylate, limonene, niacinamide, triethanolamine, caffeine, tocopheryl acetate, ascorbyl glucoside, oxothiazolidinecarboxylic acid, benzyl alcohol, geraniol, cellulose acetate butyrate, polyphosphorylcholine glycol acrylate, citral, ammonium polyacryloydimethyl taurate, castanea sativa (chestnut) seed extract, polyvinyl alcohol, sodium chloride, butylene glycol, sodium hyaluronate, fragance; may contain: iron oxides, bismuth oxychloride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS YOUTH CODE BROAD SPECTRUM SPF 15 BB 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-724
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	36 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-724-01	1 in 1 CARTON	06/01/2012
1		75 mL in 1 TUBE; Type 0: Not a Combination Product

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(49967-724)