Softlips Replenish

Dosage form: stick
Ingredients: DIMETHICONE 20mg in 1g, OCTINOXATE 75mg in 1g, OCTISALATE 30mg in 1g, OXYBENZONE 30mg in 1g
Labeler: The Mentholatum Company
NDC Code: 10742-8782

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

Octisalate - Sunscreen

Octisalate -Sunscreen

Oxybenzone - Sunscreen

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • helps prevent and temporarily protects chapped or windburned 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, euterpe oleracea [acai] fruit oil, flavor, helianthus annuus (sunflower) seed oil, menthol, myristyl alcohol, myristyl lactate, myristyl laurate, myristyl myristate, ozokerite, retinyl palmitate [vitamin A], squalane, tetrahexyldecyl ascorbate [vitamin C], vaccinium macrocarpon (cranberry) seed oil, vitamin E, white petrolatum

Questions or comments?

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

Package/Label Principal Display Panel

The Mentholatum Company

Orchard Park, NY 14127

SOFTLIPS REPLENISH 
dimethicone, octinoxate, octisalate, oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8782
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
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CETYL ALCOHOL 
ETHYLHEXYL PALMITATE 
ACAI 
SUNFLOWER OIL 
MENTHOL 
MYRISTYL ALCOHOL 
MYRISTYL LACTATE 
MYRISTYL LAURATE 
MYRISTYL MYRISTATE 
VITAMIN A PALMITATE 
SQUALANE 
TETRAHEXYLDECYL ASCORBATE 
CRANBERRY 
ALPHA-TOCOPHEROL 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:10742-8782-11 TUBE (TUBE) in 1 BLISTER PACK
12 g in 1 TUBE
2NDC:10742-8782-92 TUBE (TUBE) in 1 BLISTER PACK
22 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/12/2010
Labeler - The Mentholatum Company (002105757)

Revised: 01/2011
 
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.

Hide
(web4)