Your browser does not support JavaScript! LIP SMACKER SPF 24 COOL STRAWBERRY ORANGE (OCTINOXATE, OXYBENZONE) LIPSTICK [BONNE BELL LLC]
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LIP SMACKER SPF 24 COOL STRAWBERRY ORANGE (octinoxate, oxybenzone) lipstick
[Bonne Bell LLC]


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

ACTIVE INGREDIENTS

OCTINOXATE 7.5% W/W, OXYBENZONE 6.0% W/W, PADIMATE O 8.0% W/W.

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN

WARNINGS

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS.

DIRECTIONS

APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED.

ASK DOCTOR

CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR.

PACKAGE LABEL DISPLAY

LiP SMACKER (R)

Cool Strawberry Orange

DIST. ASPIRE BRANDS/BONNE BELL (R)
SANTA MONICA CA 90404
Made in U.S.A. net wt. 0.14 oz/4.0 g

SPF 24

lip smacker label

LIP SMACKER SPF 24 COOL STRAWBERRY ORANGE 
octinoxate, oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50051-0016
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE6 g  in 100 g
PADIMATE O (PADIMATE O) PADIMATE O8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
RICINUS COMMUNIS SEED 
CETYL ACETATE 
YELLOW WAX 
CANDELILLA WAX 
CARNAUBA WAX 
ACETYLATED LANOLIN ALCOHOLS 
SESAME OIL 
ISOPROPYL MYRISTATE 
PARAFFIN 
WHEAT GERM OIL 
MICA 
PROPYLENE GLYCOL 
STEARIC ACID 
PROPYL GALLATE 
CITRIC ACID MONOHYDRATE 
NEOTAME 
TITANIUM DIOXIDE 
D&C RED NO. 28 
D&C RED NO. 22 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (strawberry) , ORANGE (orange) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50051-0016-44 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/11/2012
Labeler - Bonne Bell LLC (004189809)
Establishment
NameAddressID/FEIBusiness Operations
Apex International015226132manufacture(50051-0016)

Revised: 10/2012
Document Id: 0bfe070d-bca0-47c0-9b7d-bd5524918de7
Set id: d2bf37db-0814-449d-b8b1-b5213aae376c
Version: 2
Effective Time: 20121011
 
Bonne Bell LLC

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