LANCOME PARIS ABSOLUE PREMIUM BX BROAD SPECTRUM SPF 15 SUNSCREEN ABSOLUTE REPLENISHING- avobenzone, octisalate and octocrylene lotion

Lancome Paris Absolue Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Replenishing by

Drug Labeling and Warnings

Lancome Paris Absolue Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Replenishing by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, SICOS ET CIE, BPS60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Octisalate 3%

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, glycerin, cyclohexasiloxane, alcohol denat., caprylic/capric triglyceride, PEG-20 methyl glucose sesquistearate, C12-15 alkyl benzoate, tocopheryl acetate, C13-14 isoparaffin, hydroxypropyl tetrahydropyrantriol, hydrolyzed malt extract, padina pavonica extract, hydrolyzed soy protein, stearic acid, adenosine, triethanolamine, polyacrylamide, calcium pantothenate, dimethyl isosorbide, limonene, xanthan gum, linalool, dioscorea villosa (wild yam) root extract, iron oxides, caprylyl glycol, capryloyl salicylic acid, paraffin, disodium EDTA, butylene glycol, cetyl alcohol, octyldodecanol, citronellol, laureth-7, hexyldecanol, fragrance

Questions or comments?

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

Monday - Friday (9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANCOME PARIS ABSOLUE PREMIUM BX BROAD SPECTRUM SPF 15 SUNSCREEN ABSOLUTE REPLENISHING 
avobenzone, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-250
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 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALCOHOL (UNII: 3K9958V90M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1)
PADINA PAVONICA (UNII: 177U06NHZI)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
STEARIC ACID (UNII: 4ELV7Z65AP)
ADENOSINE (UNII: K72T3FS567)
TROLAMINE (UNII: 9O3K93S3TK)
POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
XANTHAN GUM (UNII: TTV12P4NEE)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
PARAFFIN (UNII: I9O0E3H2ZE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
OCTYLDODECANOL (UNII: 461N1O614Y)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LAURETH-7 (UNII: Z95S6G8201)
HEXYLDECANOL (UNII: 151Z7P1317)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-250-02	1 in 1 CARTON	02/01/2010
1		75 mL in 1 BOTTLE; 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	02/01/2010

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-250)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Biocosm SARL		288479491	pack(49967-250)