Label: AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER- octinoxate, octisalate, oxybenzone, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-301-01 - Packager: Woonsocket Prescription Center, Incorporated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 11, 2011
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- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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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
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INGREDIENTS AND APPEARANCE
AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER
octinoxate, octisalate, oxybenzone, zinc oxide creamProduct 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