Your browser does not support JavaScript! SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [HUMPHREYLINE]
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SUNSCREEN (octinoxate, oxybenzone) lipstick
[Humphreyline]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Octinoxate (7.5%)

Oxybenzone (4%)

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Children under 6 months of age: ask a doctor

Aloe Barbadensis Leaf Extract, Beeswax, Ceresin, Cetyl Alcohol, Flavor, Mineral Oil, Octyl Palmitate, Paraffin, Petrolatum, Propylparaben, Tocopheryl Acetate

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Enter section text herlip balme

SUNSCREEN  
octinoxate, oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem 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) , PEACH (peach flavor) , WATERMELON (watermelon flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
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: 02/2013
Document Id: 8c468689-8275-4868-aa31-c7a4e5e59cb5
Set id: 6e460d2c-d02f-4f19-b124-d8346e6617c1
Version: 3
Effective Time: 20130201
 
Humphreyline

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