Giorgio Armani Regenessence High Lift SPF 15 by L'Oreal USA Products Inc / Sicos Et Cie (Lancome) Drug Facts

Drug Details [pdf]

GIORGIO ARMANI REGENESSENCE HIGH LIFT SPF 15- avobenzone, octisalate and octocrylene cream
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Avobenzone 3%; Octisalate 5%; Octocrylene 7%

Directions

Apply before sun exposure.

Warninigs

For external use only.

When using this product

Avoid the eye contour area. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

signs of irritation or rash appear.

Keep out of reach of children.

Do not swallow.

Inactive ingredients

water, dimethicone, glycerin, hydrogenated polisobutene, sucrose stearate, beeswax, poly c10-30 alkyl acrylate, sodium polyacrylate, phenoxyethanol, stearic acid, palmitic acid, aluminum starch octenylsuccinate, hydroxypropyl tetrahydropyrantriol, argania spinosa kernel extract, silica, caprylyl glycol, dimethicone/vinyl dimethicone crosspolymer, dimethiconol, propylene glycol, disodium stearoyl glutamate, methylparaben, acetyl trifluoromethylphenyl valyglycine, butylene glycol, disodium EDTA, pentylene glycol, ethylparaben, acrylates/c10-30 alkyl acrylate crosspolymer, sodium cocoyl glutamate, octadecendioic acid, yeast extract, magnesim ascorbyl phosphate, sodium hydroxide, peucedanum graveolens (dill) extract, adeosine, limonene, hydrolyzed linseed extract, benzyl salicylate, polyurethane-2, polymethyl methacrylate, carbomer, benzyl alcohol, linalool, alpha-isomethyl ionone, acetyl tetrapeptide-9, red 4, fragrance

image of a label

GIORGIO ARMANI REGENESSENCE HIGH LIFT SPF 15
avobenzone, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-120
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
SUCROSE STEARATE (UNII: 274KW0O50M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
PALMITIC ACID (UNII: 2V16EO95H1)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ETHYLPARABEN (UNII: 14255EXE39)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ADENOSINE (UNII: K72T3FS567)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49967-120-01	1 in 1 CARTON	12/01/2011	05/10/2017
1		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/01/2011	05/10/2017

Labeler - L'Oreal USA Products Inc (002136794)

Name	Address	ID/FEI	Business Operations
Establishment
Sicos Et Cie (Lancome)		276993581	manufacture(49967-120)

Revised: 1/2020

Document Id: 01a8e87c-5abc-4e79-b489-008d0bd80340

Set id: f637b91a-8b25-41ca-91dc-efa34cba2c95

Version: 3

Effective Time: 20200117

L'Oreal USA Products Inc