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Softlips Berry

Dosage form: ointment
Ingredients: DIMETHICONE 20mg in 1g, OCTINOXATE 75mg in 1g, OCTISALATE 30mg in 1g, OXYBENZONE 30mg in 1g
Labeler: The Mentholatum Company
NDC Code: 10742-8526

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.

Drug Facts

Active ingredients

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Oxybenzone - Sunscreen

Uses

helps protect against sunburn and chapped lips

Warnings

Stop use and ask a doctor if
  • rash or irritation develops and lasts
  • condition worsens or does not improve within 7 days

Keep out of reach of children.

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

Directions
  • apply liberally before sun exposure and as needed
  • children under 6 months of age: ask a doctor

Inactive ingredients

butylated hydroxytoulene, cetyl alcohol, ethylhexyl palmitate, flavor, menthol, myristyl alcohol, myristyl lactate, myristyl laurate, myristyl myristate, ozokerite, squalene, vitamin E, white petrolatum

Questions?

Toll free 1-877-636-2677 MON-FRI 9AM-5PM (EST) softlips.com

Package/Label Principal Display Panel

Softlips Wildberry

2 Softlips wildberry sticks!

lip protectant/sunscreen SPF 20

SOFTLIPS BERRY 
lip protectant sunscreen ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8526
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE20 mg  in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 g
OCTISALATE (OCTISALATE) OCTISALATE30 mg  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE30 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:10742-8526-12 TUBE (TUBE) in 1 BOX
12 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2010
Labeler - The Mentholatum Company (002105757)

Revised: 12/2009
Document Id: 304e3ac0-2eec-4550-8c90-555d381ca86f
Set id: 304e3ac0-2eec-4550-8c90-555d381ca86f
Version: 1
Effective Time: 20091229
 
The Mentholatum Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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