LANCOME PARIS ABSOLUE PREMIUM BX REPLENISHING AND REJUVENATING DAY- avobenzone, octisalate and octocrylene cream 
L'Oreal USA Products Inc

----------

Drug Facts

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 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, hydrogenated polyisobutene, alcohol denat., bis-PEG-18 methyl ether dimethyl silane, glycerin, cyclohexasiloxane, cetearyl alcohol, dimethicone, PEG-20, prunus armeniaca (apricot) kernel oil, petrolatum, C13-14 isoparaffin, tocopheryl acetate, hydroxypropyl tetrahydropyrantriol, hydrolyzed malt extract, sodium hyaluronate, padina pavonica extract, sodium hydroxide, hydrolyzed soy protein, adenosine, PEG-100 stearate, polyacrylamide, calcium pantothenate, dimethyl isosorbide, dimethiconol, limonene, xanthan gum, linalool, dioscorea villosa (wild yam) root extract, iron oxides, caprylyl glycol, capryloyl salicylic acid, paraffin, acrylates/C10-30 alkyl acrylate, crosspolymer, disodium EDTA, butyrospermum parkii (shea butter), butylene glycol, cetyl alcohol, cetearyl glucoside, octyldodecanol, citronellol, laureth-7, hexyldecanol, glyceryl stearate, fragrance

Questions or comments?

1-800-LANCOME (1-800-526-2663) Monday - Friday (9 am - 5 pm EST)

image of a carton

image of a carton
LANCOME PARIS ABSOLUE PREMIUM BX REPLENISHING AND REJUVENATING DAY 
avobenzone, octisalate and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-952
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone20 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene80 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-952-011 in 1 CARTON06/01/2010
150 g in 1 JAR; Type 0: Not a Combination Product
2NDC:49967-952-021 in 1 CARTON06/01/2010
275 g in 1 JAR; Type 0: Not a Combination Product
3NDC:49967-952-031 in 1 CARTON06/01/2010
315 g in 1 JAR; Type 0: Not a Combination Product
4NDC:49967-952-042 g in 1 PACKET; Type 0: Not a Combination Product06/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/01/2010
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
SICOS ET CIE276993581manufacture(49967-952) , pack(49967-952)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.185931458manufacture(49967-952) , pack(49967-952)

Revised: 12/2023
Document Id: 5be14dac-571c-478c-8c3f-464b544977cb
Set id: 08645f1d-7ba7-4410-8600-3d3f79d71385
Version: 12
Effective Time: 20231223
 
L'Oreal USA Products Inc