Your browser does not support JavaScript! LIP BALM SUNSCREEN SPF 4 CHERRY FLAVOR (SPF4 CHERRY LIP BALM) STICK [WALGREEN CO]
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LIP BALM SUNSCREEN SPF 4 CHERRY FLAVOR (spf4 cherry lip balm) stick
[Walgreen Co]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 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

  • 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 #6 (CI 15985)

Label

Card

LIP BALM SUNSCREEN SPF 4  CHERRY FLAVOR
spf4 cherry lip balm stick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-6060
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PADIMATE O (PADIMATE O) PADIMATE O1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
ARACHIDYL PROPIONATE 
WHITE WAX 
CAMPHOR (NATURAL) 
CARNAUBA WAX 
CETYL ALCOHOL 
D&C RED NO. 6 
FD&C YELLOW NO. 6 
ISOPROPYL MYRISTATE 
LIGHT MINERAL OIL 
METHYLPARABEN 
OCTYLDODECANOL 
PARAFFIN 
PROPYLPARABEN 
SACCHARIN 
LANOLIN 
PHENYL TRIMETHICONE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-6060-022 in 1 BLISTER PACK
1NDC:0363-6060-014 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/01/2013
Labeler - Walgreen Co (008965063)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
NameAddressID/FEIBusiness Operations
Lee Pharmaceuticals056425432manufacture(0363-6060)

Revised: 11/2013
 
Walgreen Co

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