SUNSCREEN - octinoxate and oxybenzone lipstick 
Humphreyline

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

Octinoxate (7.5%)

Oxybenzone (4%)

Sunscreen

Helps prevent sunburn and chapped lips

Petrolatum, Octyl Palmitate, Beeswax, Paraffin, Mineral Oil, Ceresin, Cetyl Alcohol, Fragrance, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E), Propylparaben

lip balm

SUNSCREEN 
octinoxate, oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:19392-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
ETHYLHEXYL PALMITATE 
YELLOW WAX 
PARAFFIN 
MINERAL OIL 
CERESIN 
CETYL ALCOHOL 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE 
PROPYLPARABEN 
Product Characteristics
Color    Score    
ShapeSize
FlavorTROPICAL FRUIT PUNCH (tropical flavor) , SPEARMINT (spearmint flavor) , BUBBLE GUM (bubble gum flavor) , VANILLA (vanilla flavor) , CHERRY (cherry flavor) , STRAWBERRY (strawberry flavor) , BERRY (berry flavor) , WATERMELON (watermelon flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:19392-300-014 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2010
Labeler - Humphreyline (122539042)

Revised: 2/2014
Document Id: 82e77db3-26a5-4ea6-a71e-64a319a9cebe
Set id: 6e460d2c-d02f-4f19-b124-d8346e6617c1
Version: 6
Effective Time: 20140211
 
Humphreyline