LANCOME UV EXPERT AQUAGEL DEFENSE 50 BROAD SPECTRUM SPF 50 WITH ANTIOXIDANT VITAMIN E- avobenzone, homosalate, octisalate, octocrylene and oxybenzone cream

Lancome UV Expert Aquagel Defense 50 Broad Spectrum SPF 50 with Antioxidant Vitamin E by

Drug Labeling and Warnings

Lancome UV Expert Aquagel Defense 50 Broad Spectrum SPF 50 with Antioxidant Vitamin E 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]

Drug Facts

Avobenzone 3%

Homosalate 1.7%

Octisalate 3.2%

Octocrylene 6%

Oxybenzone 3.9%

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

• 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 sunglassess
• 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, dimethicone, alcohol denat., styrene/acrylates copolymer, acrylates/dimethicone copolymer, tocopherol, sodium polyacrylate, sodium dodecylbenzenesulfonate, sodium benzoate, phenoxyethanol, PEG-8 laurate, silica, pentylene glycol, mentha piperita (peppermint) extract, propylene glycol, leontopodium alpinum flower/leaf extract, caprylyl glycol, acrylates/C-10-30 alkyl acrylate crosspolymer, sorbitol, moringa oleifera seed extract, disodium EDTA, rosa gallica flower extract, disodium phosphate, citric acid, potassium sorbate, glycerin, fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANCOME UV EXPERT AQUAGEL DEFENSE 50 BROAD SPECTRUM SPF 50 WITH ANTIOXIDANT VITAMIN E 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-248
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	107 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	32 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	39 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-8 LAURATE (UNII: 762O8IWA10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LEONTOPODIUM ALPINUM FLOWER (UNII: MWN6IZU3XM)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITOL (UNII: 506T60A25R)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ROSA GALLICA FLOWER (UNII: X8W61WUV70)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-248-01	1 in 1 CARTON	01/15/2018
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-248-02	1 in 1 CARTON	01/15/2018
2		10 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-248-03	1 in 1 CARTON	01/15/2018
3		5 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 49967-248-04	1 in 1 CARTON	01/15/2018
4		1 mL in 1 TUBE; 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	01/15/2018

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-248)