COVERGIRL NATURELUXE  SPF 15 GLOSS BALM- octinoxate lipstick 
Noxell

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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COVERGIRL®
natureluxe™
SPF
15
ALL SHADES

ACTIVE INGREDIENT

OCTINOXATE 7% W/W.

PROCTER & GAMBLE, DISTR., HUNT VALLEY, MD 21030 /TORONTO, ON M5W 1C5

DIRECTIONS

APPLY BEFORE SUN EXPOSURE.

WARNING

STOP USE AND CONSULT DOCTOR IF RASH OR IRRITATION DEVELOPS OR LASTS.

KEEP OUT OF REACH OF CHILDREN.

INACTIVE INGREDIENT

Ricinus Communis (Castor) Seed Oil, Lanolin Oil, Polybutene, Lanolin, Petrolatum, Ozokerite, Oleyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Ethylhexyl Hydroxystearate, Cetyl Alcohol, Paraffin, Acetylated Lanolin Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkii (Shea) Butter, Fragrance, Glyceryl Oleate, Cocos Nucifera (Coconut) Oil, Propylparaben, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Ascorbyl Palmitate, Synthetic Fluorphlogopite, Propylene Glycol. May contain: Mica, Titanium Dioxide, Yellow 5 Lake, Red 6 Lake, Iron Oxides, Bismuth Oxychloride, Red 7 Lake, Red 27 Lake, Blue 1 Lake, Carmine

PRINCIPAL DISPLAY PANEL - 1.9 g Cylinder Label

COVERGIRL®

natureluxe

luxury touched by nature

SPF
15

sunscreen

205

gloss balm

1.9 g (.067 oz)

DIN 02346036
Octinoxate stick

Principal Display Panel - 1.9 g Cylinder Label
COVERGIRL NATURELUXE   SPF 15 GLOSS BALM
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:22700-112
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Castor Oil 
Lanolin 
Petrolatum 
Oleyl Alcohol 
Candelilla Wax 
Ethylhexyl Hydroxystearate 
Cetyl Alcohol 
Paraffin 
Cocoa Butter 
Shea Butter 
Glyceryl Oleate 
Coconut Oil 
Propylparaben 
Aloe Vera Leaf 
Ascorbyl Palmitate 
Propylene Glycol 
Mica 
Titanium Dioxide 
FD&C Yellow NO. 5 
Aluminum Oxide 
D&C Red NO. 6 
Bismuth Oxychloride 
D&C Red No. 7 
D&C Red NO. 27 
FD&C Blue NO. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22700-112-011.9 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/15/201008/22/2014
Labeler - Noxell (003082997)
Establishment
NameAddressID/FEIBusiness Operations
Noxell Corp003082997MANUFACTURE(22700-112)

Revised: 1/2013
Document Id: 98dfd91b-5642-44e4-b70b-890f501e44d3
Set id: ae3bd6c3-9e8e-4750-9cd0-cf38dbf0440f
Version: 2
Effective Time: 20130129
 
Noxell