LIP SMACKER SPF 24 COOL STRAWBERRY ORANGE- octinoxate, oxybenzone lipstick

Lip Smacker SPF 24 Cool Strawberry Orange by

Drug Labeling and Warnings

Lip Smacker SPF 24 Cool Strawberry Orange by is a Otc medication manufactured, distributed, or labeled by Bonne Bell LLC, Apex International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LIP SMACKER SPF 24 COOL STRAWBERRY ORANGE 
octinoxate, oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50051-0016
Route of Administration	TOPICAL

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	STRAWBERRY (strawberry) , ORANGE (orange)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50051-0016-4	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(50051-0016)