LANCOME PARIS ABSOLUE HAND PREMIUM BX BROAD SPECTRUM SPF 15 SUNSCREEN ABSOLUTE ANTI AGE SPOT UNIFYING AND REPLENISHING TREATMENT- avobenzone, octisalate and octocrylene lotion

Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment by

Drug Labeling and Warnings

Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment 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

Avobenzone 2%

Octisalate 5%

Octocrylene 10%

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:

● shake well

● apply generously and evenly 15minutes 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, alcohol denat., glyceryl stearate, theobroma cacao (cocoa) seed butter, squalane, silica, PEG-100 stearate, glycol distearate, oryza sativa (rice) bran oil, butylene glycol, tocopheryl acetate, lactic acid, vaccinium myrtillus fruit extract, saccharum officinarum (sugar cane) extact, padina pavonica extract, stearic acid, pehnoxyethanol, acer saccharum (sugar maple) extract, palmitic acid, chlorphenesin, polysorbate 80, chlorhexidine digluconate, dimethicone, ammonium polyacryloyldimethyl taurate, dimethiconol, limonene, xanthan gum, linalool, ginkgo biloba leaf extract, dioscorea villosa (wild yam) root extract, propylene glycol, isohexadecane, iron oxides, paraffin, acrylamide/sodium acryloyldimethyltaurate copolymer, rosa centifolia flower extract, tetrasodium EDTA, citrus aurantium dulcis (orange) fruit water, citrus limon (lemon) fruit extract, citronellol, citral, hexyldecanol, glycine soja (soybean) protein, glycyrrhiza glabra (licorice) root extrract, fragrance, sodium benzoate

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 HAND PREMIUM BX BROAD SPECTRUM SPF 15 SUNSCREEN ABSOLUTE ANTI AGE SPOT UNIFYING AND REPLENISHING TREATMENT 
avobenzone, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-137
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-137-01	1 in 1 CARTON	01/01/2004
1		100 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-137-02	1 in 1 CARTON	01/01/2004
2		30 g 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	01/01/2004

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-137)