MALLY LIP DEFENDER - avobenzone, octinoxate gel 
MallyGirl, 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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mally Lip Defender - Empowering Pink - Broad Spectrum SPF 15

DRUG FACTS


Active Ingredients

Avobenzone 2.0%

Octinoxate 7.0%

Purpose

Sunscreen

Sunscreen

Use

For external use only

Do not use on damaged or broken skin.

Stop use and ask doctor if rash occurs.

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

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

Directions

Inactive Ingredients

Polybutene, Helianthus annuus (sunflower) seed oil, Polyglyceryl-2  triisostearate, Octyldecanol, Euphorbia cerifera (candelilla) wax (candelilla cera), Trihydroxystearin, Copernicia cerifera (carnauba) wax (cera carnauba),  Microcrystalline wax (microcristallina cera), Phospholipids, Calcium aluminum borosilicate, Calcium sodium borosilicate, Tocopheryl acetate, Silica, Sodium chondroitin sulfate, Saccharomyces cerevisiae extract, Hyaluronic acid, Tocopherol, Alumina, Tripeptide-29, Tin oxide, Titanium dioxide (CI 77891) May Contain: Mica (CI 77019), Red 28 Lake (CI 45410), Yellow 5 Lake (CI 19140), Red 6 (CI 15850), Red 7 Lake (CI 15850), Yellow 6 Lake (CI 15985), Iron Oxides (CI 77491, CI 77492, CI 77499), Blue 1 Lake (CI 42090)

Other Information

Principal Display Panel

mally

Lip Defender
Empowering Pink
duos with sunscreen
Broad Spectrum SPF 15

Tube Label
Drug Facts Label Carton





MALLY LIP DEFENDER 
avobenzone, octinoxate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76119-5305
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.07 g  in 3.5 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE.245 g  in 3.5 g
Inactive Ingredients
Ingredient NameStrength
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
OCTYLDECANOL (UNII: 07UG7TSU58)  
CANDELILLA WAX (UNII: WL0328HX19)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
HYALURONIC ACID (UNII: S270N0TRQY)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 6 (UNII: 481744AI4O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76119-5305-11 in 1 BOX
13.5 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2012
Labeler - MallyGirl, LLC (167262554)

Revised: 5/2012
Document Id: e0107e7b-3575-471e-a011-5869c6a0d874
Set id: 6262a1d6-62dc-4c82-96f1-c9e252d6afeb
Version: 1
Effective Time: 20120501
 
MallyGirl, LLC