LIP BALM SUNSCREEN SPF 4 ORIGINAL- spf4 lip balm stick

Lip Balm Sunscreen SPF 4 by

Drug Labeling and Warnings

Lip Balm Sunscreen SPF 4 by is a Otc medication manufactured, distributed, or labeled by Walgreen Co, Lee Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Padimate O, 1.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

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

Do not use on damaged or broken skin

WHEN USING

When using this product, keep out of eyes.  Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor

Other information

• protect this product from excessive heat and direct sunlight

Inactive ingredients

Petrolatum, paraffinum liquidum (mineral oil), ozokerite, octyldodecanol, phenyl methicone, flavor, arachidyl propionate, cera alba (beeswax), camphor, copernicia cerifera (carnauba) wax, isopropyl lanolate, isopropyl myristate, lanolin, paraffin, cetyl alcohol, saccharin, methylparaben, propylparaben, D&C red #6 (CI 15850), FD&C yellow #5 (CI 19140)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIP BALM SUNSCREEN SPF 4  ORIGINAL
spf4 lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-6050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
WHITE WAX (UNII: 7G1J5DA97F)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
METHYLPARABEN (UNII: A2I8C7HI9T)
OCTYLDODECANOL (UNII: 461N1O614Y)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN (UNII: FST467XS7D)
LANOLIN (UNII: 7EV65EAW6H)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-6050-02	2 in 1 BLISTER PACK
1	NDC: 0363-6050-01	4 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/01/2013

Labeler - Walgreen Co (008965063)

Registrant - Lee Pharmaceuticals (056425432)

Establishment
Name	Address	ID/FEI	Business Operations
Lee Pharmaceuticals		056425432	manufacture(0363-6050)