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 Type HUMAN OTC DRUG Item Code (Source) NDC:19392-300
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM (UNII: 4T6H12BN9U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MINERAL OIL (UNII: T5L8T28FGP)  
CERESIN (UNII: Q1LS2UJO3A)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Color      Score     
Shape Size
Flavor TROPICAL 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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:19392-300-01 4 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2010
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