SWEET BERRY MOISTURIZING SUNSCREEN LIP BALM SPF 15- ethylhexyl methoxycinnamate lipstick
Tween Brands 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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Sweet Berry Moisturizing Sunscreen Lip Balm SPF 15

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.

Berry Moisturizing Sunscreen Lip Balm SPF 15

image description

SWEET BERRY MOISTURIZING SUNSCREEN LIP BALM SPF 15
ethylhexyl methoxycinnamate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60637-115
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60637-115-00	1 in 1 BOX	09/02/2016
1		3.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - Tween Brands Inc (965758188)