LIP BALM- octinoxate oxybenzone zinc oxide ointment

LIP BALM by

Drug Labeling and Warnings

LIP BALM by is a Otc medication manufactured, distributed, or labeled by Kamins Dermatologics Inc., Odan Laboratories Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

OCTINOXATE 7.5%

OXYBENZONE 5.0%

ZINC OXIDE 4.0%

PURPOSE

Purpose: Sunscreen product

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

INDICATIONS & USAGE

A soothing treatment balm that helps heal and protect lips from sun, wind and extreme tempera- tures. Repairs happed, sore lips with Bio-MapleTM compound and skin softening oils. Also helps prevent the breakout of lip sores with broad spectrum UVA/UVB sun screening agents. Creates a smoother palette for lipstick application by diminishing the appearance of lip lines and reducing the feathering of lip color. Use anytime for fuller, more luscious lips

Uses

helps prevent sunburn

higher SPF gives more sunburn protection

provides moderate protection against sunburn

WARNINGS

Warnings

For external use only.

When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Sun alert: limiting sun exposure, earing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

DOSAGE & ADMINISTRATION

Directions

Using the angled tube applicator, squeeze tube and apply directly to lips 15-30 minutes before sun exposure. Reapply as needed, especially after prolonged sun exposure, drinking or eating.

Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients: Polybutene, ricinus communis (castor) seed oil, petrolatum, VP/hexadecene copolymer, cera alba (beeswax), cyclopentasiloxane/dimethicone crosspolymer, caprylic/capric triglyceride, squalane, copernicia cerifera (carnauba wax), paraffin, tocopheryl acetate, acer saccharum (maple isolate), flavour/aroma, benzyl benzoate.

B. KAMINS LIP BALM SPF 20 box

B. KAMINS
LIP BALM SPF 20
15 G / 0.5 oz
DIN 02248084

INGREDIENTS AND APPEARANCE

LIP BALM 
octinoxate oxybenzone zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63550-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CASTOR OIL (UNII: D5340Y2I9G)
PETROLATUM (UNII: 4T6H12BN9U)
1-HEXADECENE (UNII: 97T015M2UX)
WHITE WAX (UNII: 7G1J5DA97F)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRICAPRIN (UNII: O1PB8EU98M)
TRICAPRYLIN (UNII: 6P92858988)
SQUALANE (UNII: GW89575KF9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PARAFFIN (UNII: I9O0E3H2ZE)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ACER SACCHARUM SAP (UNII: 75UOH57984)
BENZYL BENZOATE (UNII: N863NB338G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63550-114-01	15 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2004

Labeler - Kamins Dermatologics Inc. (254050784)

Registrant - Odan Laboratories Ltd (208585604)

Establishment
Name	Address	ID/FEI	Business Operations
Odan Laboratories Ltd		208585604	manufacture(63550-114) , pack(63550-114)