GAP FAVORITE LIP BALM POMEGRANATE SPF 18- octinoxate and oxybenzone stick 
Autumn Harp, Inc

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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Drug facts

Active Ingredients

Active Ingredients         Purpose

Octinoxate 7.5%         Sunscreen

Oxybenzone 6%         Sunscreen

Purpose

Warning

Warnings

For external use only

When using this product

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

Stop use

Stop use and ask a doctor if rash and irritation develops and lasts

Keep out of reach of children

Keep out of reach of children. If swolloed get medical help or contact Poison Control right away.

Directions

Sun Alert

Other Information

Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin cancer, and harmful effects of the sun.

Inactive Ingredients

Inactive Ingredients:  Hydrogenated Coconut Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Ammonium Glycyrrhizate, Glycine Soja (Soybean) Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Lecithin, Rosmarinus Officinalis (Rosemary) Leaf Extract.

Label

R05193 label

GAP FAVORITE LIP BALM  POMEGRANATE SPF 18
octinoxate and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0218
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
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CANDELILLA WAX (UNII: WL0328HX19)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ROSEMARY (UNII: IJ67X351P9)  
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0218-14 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/16/2011
Labeler - Autumn Harp, Inc (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc064187883manufacture

Revised: 11/2011
Document Id: b8815d31-bc15-4afd-8f86-3f8564eda7d0
Set id: 01c0a87e-52a3-48ca-8a08-5ec489e2d6f3
Version: 1
Effective Time: 20111116
 
Autumn Harp, Inc