LANCOME PARIS BB BIENFAIT TEINTE BEAUTY BALM BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate and titanium dioxide cream 
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Octinoxate 7.5%

Titanium dioxide 5.8%

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 generously and evenly 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, cyclopentasiloxane, cyclohexasiloxane, glycerin, pheny trimethicone, polyglyceryl-4 isostearate, hexyl laurate, cetyl PEG/PPG-10/1 dimethicone, disteardimonium hectorite, pentylene glycol, moringa pterygosperma seed extract, triethanolamine, trihydroxystearin, silica, alumina, aluminum hydroxide, magnesium sulfate, alcohol denat., ascorbyl gluycoside, disodium stearoyl glutamate, acetylated glycol stearate, panthenol, castanea sativa (chestnut) seed extarct, tocopheryl acetate, methylparaben, phenoxyethanol, diazolidinyl urea, linalool, geraniol, alpha-isomethyl ionone, citronellol, benzyl alcohol, benzyl salicylate, fragrance; may contain: titanium dioxide, iron oxides

1-800-LANCOME (1-800-526-2663)

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LANCOME PARIS BB BIENFAIT TEINTE BEAUTY BALM BROAD SPECTRUM SPF 30 SUNSCREEN 
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-384
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE58 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-384-011 in 1 CARTON08/01/201307/21/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201307/21/2021
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc.076693183pack(49967-384)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.185931458manufacture(49967-384)

Revised: 1/2023
 
L'Oreal USA Products Inc