GAP Favorite Lip Balm Berry Punch SPF 18

GAP FAVORITE LIP BALM BERRY PUNCH 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.

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 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
(click image for full-size original)

GAP FAVORITE LIP BALM BERRY PUNCH SPF 18
octinoxate and oxybezone stick
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51514-0217
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 6 g in 100 g
Inactive Ingredients
Ingredient Name Strength
HYDROGENATED COCONUT OIL
OLIVE OIL
YELLOW WAX
CANDELILLA WAX
CALENDULA OFFICINALIS FLOWER
TOCOPHEROL
ALPHA-TOCOPHEROL ACETATE
ROSEMARY
ECHINACEA, UNSPECIFIED
AMMONIUM GLYCYRRHIZATE
Product Characteristics
Color Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51514-0217-1 4 g in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/21/2011
Labeler — Autumn Harp, Inc (064187883)
Establishment
Name Address ID/FEI Operations
Autumn Harp, Inc 064187883 manufacture

Revised: 11/2011 Autumn Harp, Inc

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