Gap Favorite Lip Balm
FDA Label NDC 51514-0217

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Autumn Harp, Inc for the product Gap Favorite Lip Balm (NDC 51514-0217). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, warning, when using tis product, stop use, keep out of reach of children, directions, sun alert, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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 Tis Product

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

  • 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 harmful effects of the sun.

Inactive Ingredient

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

Label

Gap Beery Punch Label (R05539)

Gap Beery Punch Label (R05539)

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