Softlips Pure Lip Butter Vanilla Berry

Dosage form: ointment
Ingredients: ZINC OXIDE 55mg in 1g
Labeler: The Mentholatum Company
NDC Code: 10742-6761

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 ingredient

Zinc oxide 5.5%

Purpose

Zinc oxide - Sunscreen

Uses
  • helps prevent sunburn
  • provides UVA and UVB protection

Warnings

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

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

butyrospermum parkii (shea butter), ricinus communis (castor) seed oil, lanolin, beeswax, simmondsia chinensis (jojoba) seed oil, flavor, polyglyceryl-3 beeswax, lanolin wax, theobroma cacao (cocoa) seed butter, silica, garcinia indica seed butter, mangifera indica (mango) seed oil, shorea stenoptera [illipe] seed butter, euterpe oleracea [acai berry] fruit oil, tocopherol [vitamin E], jojoba esters, polyhydroxystearic acid, vanilla planifolia fruit extract

Questions?

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

Package/Label Principal Display Panel

Softlips Pure vanilla berry

hydrating lip butter

natural protection for very dry lips

100% natural

Distributed by:

The Mentholatum Company

Orchard Park, NY 14127

SOFTLIPS PURE  LIP BUTTER VANILLA BERRY
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-6761
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE55 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:10742-6761-11 TUBE (TUBE) in 1 BLISTER PACK
110 g in 1 TUBE
2NDC:10742-6761-210 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2010
Labeler - The Mentholatum Company (002105757)

Revised: 06/2010
 
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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