AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER- octinoxate, octisalate, oxybenzone, zinc oxide cream

age renewal firming and hydrating moisturizer by

Drug Labeling and Warnings

age renewal firming and hydrating moisturizer by is a Otc medication manufactured, distributed, or labeled by Woonsocket Prescription Center, Incorporated, AMCOL Health & Beauty Solutions, Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:  Octinoxate 7.5%, Octisalate 5%, Oxybenzone 4%, Zinc Oxide 2%

PRINCIPAL DISPLAY PANEL

GENERAL PRECAUTIONS

Caution:  For external use only.  Avoid getting into eyes.  If product gets into eyes, rinse thoroughly with water.  In the beginning you may experience mild tingling, warming, flaking and/or redness.  This is a sign that the product is working.  If discomfort occurs reduce use to every other day until your skin adjusts.  Discontinue use if irritation occurs.

STOP USE

Discontinue use if irritation occurs.

INGREDIENTS AND APPEARANCE

AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER 
octinoxate, octisalate, oxybenzone, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.04 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
isopropyl myristate (UNII: 0RE8K4LNJS)
cetostearyl alcohol (UNII: 2DMT128M1S)
squalane (UNII: GW89575KF9)
phenoxyethanol (UNII: HIE492ZZ3T)
retinol (UNII: G2SH0XKK91)
polysorbate 20 (UNII: 7T1F30V5YH)
arginine (UNII: 94ZLA3W45F)
soybean (UNII: L7HT8F1ZOD)
.alpha.-tocopherol acetate, DL- (UNII: WR1WPI7EW8)
Picea abies wood (UNII: 72GZ8K8996)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
cetearyl glucoside (UNII: 09FUA47KNA)
bentonite (UNII: A3N5ZCN45C)
xanthan gum (UNII: TTV12P4NEE)
sorbitol (UNII: 506T60A25R)
sodium borate (UNII: 91MBZ8H3QO)
sodium hydroxide (UNII: 55X04QC32I)
methylparaben (UNII: A2I8C7HI9T)
ethylhexylglycerin (UNII: 147D247K3P)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
ascorbic acid (UNII: PQ6CK8PD0R)
edetate disodium (UNII: 7FLD91C86K)
panthenol (UNII: WV9CM0O67Z)
titanium dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-301-01	1 in 1 CARTON
1		51 g in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/22/2009

Labeler - Woonsocket Prescription Center, Incorporated (062312574)

Registrant - AMCOL Health & Beauty Solutions, Incorporated (872684803)

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Incorporated		872684803	manufacture