Gap favorite Lip Balm Strawberry Kiwi

Dosage form: stick
Ingredients: OCTINOXATE 7.5g in 100g, OXYBENZONE 6g in 100g
Labeler: Autumn Harp, Inc
NDC Code: 51514-0213

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.

DRUG FACTS

ACTIVE INGREDIENTS

Active Ingredients         Purpose

Octinoxate 7.5%            Sunscreen

oxybenzone 6%             Sunscreen


Purpose
  • lip moisturizer
  • helps prevent sunburn
  • higher SPF gives more sunburn protection

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 swallowed get medical help or contact Poison Control right away.

Directions

Directions:

  • apply liberally before sun exposure and as needed
  • children under 6 months of age: ask doctor

Sun Alert

Other information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin cancer, and other harmfu; 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

GAP FAVORITE LIP BALM  STRAWBERRY KIWI
octinoxate and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0213
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED COCONUT OIL 
OLIVE OIL 
YELLOW WAX 
CANDELILLA WAX 
CALENDULA OFFICINALIS FLOWER 
TOCOPHEROL 
ROSEMARY 
ECHINACEA, UNSPECIFIED 
AMMONIUM GLYCYRRHIZATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (STRAWBERRY KIWI) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51514-0213-14 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/17/2011
Labeler - Autumn Harp, Inc (064187883)
Establishment
NameAddressID/FEIOperations
Autumn Harp, Inc064187883manufacture

Revised: 11/2011
 
Autumn Harp, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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