LIP HEALER SPF 15- oxybenzone, padimate o stick

Lip Healer SPF 15 by

Drug Labeling and Warnings

Lip Healer SPF 15 by is a Otc medication manufactured, distributed, or labeled by Continental Vitamin Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Benzophenone-3 (Oxybenzone) 3%

Ethylhexyl Dimethyl PABA (Padimate O) 7%

Purpose

Sunscreen

Uses

Helps prevent sunburn lips

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging For external use only

For external use only

Do not use

• on damaged or broken skin

Stop use and ask a doctor

• if rash occurs

When using this product

• keep out of eyes. Rinse with water to remove

Keep out of reach of children.

• if swallowed, get medical help or contact a Poison Control Center right away

Directions

Apply liberally to lips 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor

Inactive ingredient

Aloe Barbadensis (Aloe Vera) Leaf Extract, Calendula Officinalis Flower Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cera Alba (Beeswax), Cetyl Alcohol, Citrus Aurantium Dulcis (Orange) Oil, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Glycine Soja (Soybean) Oil, Ozokerite, Retinyl Palmitate, Chamomilla Recutita (Matricaria) Flower Extract, Tocopherol (Vitamin E)

Other information

Protect this product from excessive heat and direct sun

Questions or comments?

Call 1-800-421-6175

​Package Labeling:

INGREDIENTS AND APPEARANCE

LIP HEALER SPF 15 
oxybenzone, padimate o stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 38176-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SAFFLOWER OIL (UNII: 65UEH262IS)
WHITE WAX (UNII: 7G1J5DA97F)
CETYL ALCOHOL (UNII: 936JST6JCN)
ORANGE OIL (UNII: AKN3KSD11B)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
SOYBEAN OIL (UNII: 241ATL177A)
CERESIN (UNII: Q1LS2UJO3A)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHAMOMILE (UNII: FGL3685T2X)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 38176-001-24	24 in 1 CARTON	05/26/2016
1		4.25 g in 1 TUBE; 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	05/26/2016

Labeler - Continental Vitamin Company Inc (057333080)