LIP BALM SUNSCREEN SPF 4 CHERRY FLAVOR- padimate o stick 
Walgreen Co

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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Drug Facts

Active ingredients

Padimate O, 1.5%

Purpose

Sunscreen

Uses

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

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

Directions

Other information

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 #6 (CI 15985)

Label

Card

LIP BALM SUNSCREEN SPF 4  CHERRY FLAVOR
spf4 cherry lip balm stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6060
Route of Administration TOPICAL DEA Schedule     
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. 6 (UNII: H77VEI93A8)  
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:0363-6060-02 2 in 1 BLISTER PACK
1 NDC:0363-6060-01 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(0363-6060)

Revised: 11/2013
Document Id: 1210cd47-4d41-4c70-9a9b-c8e195733041
Set id: c19a6079-9d15-49da-9edb-4bc12ba5ddab
Version: 2
Effective Time: 20131115
 
Walgreen Co