LANCOME PARIS ABSOLUE PRECIOUS CELLS SUNSCREEN REPAIRING AND RECOVERING DAY- avobenzone, octisalate and octocrylene cream

Lancome Paris Absolue Precious Cells Sunscreen Repairing and Recovering Day by

Drug Labeling and Warnings

Lancome Paris Absolue Precious Cells Sunscreen Repairing and Recovering Day by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, SICOS ET CIE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

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, cyclohexasiloxane, glycerin, bis-PEG-18 methyl ether dimethyl silane, alcohol denat., cetearyl alcohol, PEG-20, petrolatum, C13-14 isoparaffin, zea mays (corn) oil, tocopheryl acetate, hydroxypropyl tetrahydropyrantriol, hydrolyzed soy protein, red 4, phenoxyethanol, adenosine, PEG-100 stearate, ethylparaben, triethanolamine, polyacrylamide, malus domestica fruit cell culture, yellow 5, dimethyl isosorbide, dimethicone, dimethiconol, limonene, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, linalool, 2-oleamide-1,3- octadecanediol, capryloyl salicylic acid, acrylates/C10-30 alkyl acrylate crosspolymer, passiflora edulis seed oil, disodium EDTA, castanea sativa (chestnut) seed extract, butyrospermum parkii (shea butter), cetyl alcohol, butylene glycol, octyldodecanol, cetearyl glucoside, methylparaen, citronellol, prunus armeniaca (apricot) kernel oil, laureth-7, coumarin, oryza sativa (rice) bran oil, glyceryl stearate, fragrance

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANCOME PARIS ABSOLUE PRECIOUS CELLS SUNSCREEN REPAIRING AND RECOVERING DAY 
avobenzone, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-166
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERIN (UNII: PDC6A3C0OX)
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
ALCOHOL (UNII: 3K9958V90M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PETROLATUM (UNII: 4T6H12BN9U)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CORN OIL (UNII: 8470G57WFM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ADENOSINE (UNII: K72T3FS567)
PEG-100 STEARATE (UNII: YD01N1999R)
ETHYLPARABEN (UNII: 14255EXE39)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
DIMETHICONE (UNII: 92RU3N3Y1O)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
9-OCTADECENAMIDE, N-(2-HYDROXY-1-(HYDROXYMETHYL)HEPTADECYL)-, (9Z)- (UNII: 30D478BUNR)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECANOL (UNII: 461N1O614Y)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
METHYLPARABEN (UNII: A2I8C7HI9T)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
LAURETH-7 (UNII: Z95S6G8201)
COUMARIN (UNII: A4VZ22K1WT)
RICE BRAN OIL (UNII: LZO6K1506A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-166-01	1 in 1 CARTON	08/01/2009
1		50 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 49967-166-02	15 g in 1 JAR; Type 0: Not a Combination Product	08/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2009

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-166)