LIP HEALER- oxybenzone, padimate o stick

LIP HEALER by

Drug Labeling and Warnings

LIP HEALER by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTSActive Ingredients

Benzophenone-3 (Oxybenzone) 3%

Ethylhexyl Dimethyl PABA (Palimate O) 7%

Purpose

Sunscreen

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Do not use

on damaged or broken skin

Stop use and ask a doctor

if rash develops

When using this product

keep out of eyes. Rinse with water to remove

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 800-421-6175

LIP HEALER - product label

LIP HEALER®

PETROLEUM FREE/NOT TESTED ON ANIMALS

SPF-15

ALOE VERA

essence of nature ®

NET WT 0.15 oz. (4.25g)

VITAMIN E CALENDULA CHAMOMILE

ESSENCE OF NATURE L.A., CA 90058

(800) 421-6175www.cvc4health.com

DRUG FACTS Lift label for more drug facts

SAFETY SEAL

NATURAL FORMULA
"SOOTHES AND PROTECTS"

HELPS PREVENT CHAPPED AND SUNBURNED LIPS

24 Tubes 0.15 oz ( 4.25g) each 

INGREDIENTS AND APPEARANCE

LIP HEALER 
oxybenzone, padimate o stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.1275 g  in 4.25 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	0.2975 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SAFFLOWER OIL (UNII: 65UEH262IS)
YELLOW WAX (UNII: 2ZA36H0S2V)
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)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-126-50	4.25 g in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2005

Labeler - Bentley Laboratories, LLC (068351753)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(54111-126)