LIP SMACKER SPF 24 LEMON LIME RUSH - octinoxate, oxybenzone and padimate o lipstick 
Bonne Bell LLC

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.

----------

Lip Smacker SPF 24 Lemon Lime Rush

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)

Lemon Lime Rush

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 LEMON LIME RUSH 
octinoxate, oxybenzone lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50051-0019
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g  in 100 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O 8 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
CETYL ACETATE (UNII: 4Q43814HXS)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
SESAME OIL (UNII: QX10HYY4QV)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
WHEAT GERM OIL (UNII: 14C97E680P)  
MICA (UNII: V8A1AW0880)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
NEOTAME (UNII: VJ597D52EX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
Product Characteristics
Color      Score     
Shape Size
Flavor LEMON (lemon) , LIME (lime) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50051-0019-4 4 g in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/11/2012
Labeler - Bonne Bell LLC (004189809)
Establishment
Name Address ID/FEI Business Operations
Apex International 015226132 manufacture(50051-0019)

Revised: 10/2012
Document Id: 501e08e6-2970-46f8-ac50-e222f62855e8
Set id: f25afcba-e63c-4474-ac23-073568344611
Version: 3
Effective Time: 20121016
 
Bonne Bell LLC