FLOUNDER SUN SMACKER SPF 24 WATERMELON WAVE  - octinoxate, oxybenzone, 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.

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Flounder Sun Smacker SPF 24 Watermelon Wave

Drug Facts

ACTIVE INGREDIENTS

Octinoxate 7.5 percent w per w

Oxybenzone 6.0 percent w per w

Padimate 0 8.0 percent w per w

PURPOSES

Sunscreen

USE

HELPS PREVENT SUNBURN.

WARNINGS

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 help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

on damaged or broken skin

Stop use and ask a doctor

if rash occurs

When using this product

keep out of eyes. Rinse with water to remove

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

DIRECTIONS

Storage and Handling

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENTS

RICINUS COMMUNIS (CASTOR) SEED OIL, CETYL ACETATE, BEESWAX (CERA ALBA), EUPHORBIA CERIFERA (CANDELILLA) WAX, FLAVOR/AROMA, POLYBUTENE, COPERNICIA CERIFERA (CARNAUBA) WAX, OZOKERITE, ACETYLATED LANOLIN ALCOHOL, SESAMUM INDICUM (SESAME) SEED OIL, ISOPROPYL MYRISTATE, BENZYL BENZOATE, PARAFFIN, POLYESTER-3, TRITICUM VULGARE (WHEAT) GERM OIL, MICA, PROPYLENE GLYCOL, STEARIC ACID, HYDROGENATED SOY GLYCERIDES, PROPYL GALLATE, CITRIC ACID, NEOTAME, CITRAL, LINALOOL, BENZYL ALCOHOL, GERANIOL, METHYL 2-OCTYNOATE, CINNAMAL, EUGENOL, FARNESOL, LIMONENE. MAY CONTAIN (PLUS OR MINUS) TITANIUM DIOXIDE (CI 77891), BLUE 1 LAKE (CI 42090), RED 28 (CI 45410), RED 6 LAKE (CI 15850), RED 22 (CI 45380), YELLOW 5 LAKE (CI 19140), CARMINE (CI 75470).

Questions or Comments

Call 1-866-984-1433

Package Label

SUNSCREEN LIP BALM SPF 24
SUN SMACKER
Watermelon Wave

(c) Disney
DIST. ASPIRE BRANDS/BONNE BELL (R)
SANTA MONICA CA 90404 N-1703 SARPSBORG NORWAY
Made in U.S.A.   net wt 0.14 oz 4.0 g

flounder label 1
flounder label 2
FLOUNDER SUN SMACKER SPF 24 WATERMELON WAVE  
octinoxate, oxybenzone, padimate o lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50051-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
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)  
BENZYL BENZOATE (UNII: N863NB338G)  
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)  
CITRAL (UNII: T7EU0O9VPP)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GERANIOL (UNII: L837108USY)  
METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
CINNAMALDEHYDE (UNII: SR60A3XG0F)  
EUGENOL (UNII: 3T8H1794QW)  
FARNESOL (UNII: EB41QIU6JL)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 6 (UNII: 481744AI4O)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
Color    Score    
ShapeSize
FlavorWATERMELON (watermelon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50051-0002-44 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/06/2012
Labeler - Bonne Bell LLC (004189809)

Revised: 9/2012
Document Id: 36b6d2c0-b068-491b-87d0-529fb985ff57
Set id: 0d2f4af8-6c1a-47c2-983d-a34000e047be
Version: 2
Effective Time: 20120906
 
Bonne Bell LLC