FRESH MINT MOISTURIZING SUNSCREEN LIP BALM SPF 15- ethylhexyl methoxycinnamate lipstick

Fresh Mint Moisturizing Sunscreen Lip Balm SPF 15 by

Drug Labeling and Warnings

Fresh Mint Moisturizing Sunscreen Lip Balm SPF 15 by is a Otc medication manufactured, distributed, or labeled by Tween Brands Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethylhexyl Methoxycinnamate 3.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warning

• For external Use only
• Do not use on damaged or broken skin.
• When using this product keep out of eyes.
• Rinse with water to remove.
• Stop use and ask a doctor if rash occurs.

Keep out of the reach of children

If product is swallowed get medical help or contact a Poison Control Center in area.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.

Inactive Ingredients

Mineral Oil, Ozokerite, Ethylhexyl Palmitate, Polybutene, Cera alba, Synthetic wax, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Extract, Fragrance, Tocopheryl acerare.

Fresh Mint Moisturizing Sunscreen Lip Balm SPF 15

INGREDIENTS AND APPEARANCE

FRESH MINT MOISTURIZING SUNSCREEN LIP BALM SPF 15 
ethylhexyl methoxycinnamate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60637-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	122.5 mg  in 3.5 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60637-116-00	1 in 1 BOX	09/02/2016
1		3.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/02/2016

Labeler - Tween Brands Inc (965758188)