Softlips Watermelon

Dosage form: stick
Ingredients: DIMETHICONE 20mg in 1g, OCTINOXATE 75mg in 1g, OCTISALATE 30mg in 1g, OXYBENZONE 30ug in 1g
Labeler: The Mentholatum Company
NDC Code: 10742-8476

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

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Oxybenzone - Sunscreen

Keep Out of Reach of Children

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

Uses
  • helps prevent sunburn
  • temporarily protects chapped or cracked lips

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increased your risk of skin cancer and early skin aging. This product has been shown only to 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
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor

Inactive ingredients

ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetate [vitamin E]

Package/Label Principal Display Panel

Package/Label Principal Display Panel
SOFTLIPS  WATERMELON
dimethicone, octinoxate, octisalate, oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8476
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 ug  in 1 g
Inactive Ingredients
Ingredient NameStrength
CERESIN 
SQUALANE 
ETHYLHEXYL PALMITATE 
PETROLATUM 
MYRISTYL MYRISTATE 
MYRISTYL LACTATE 
CETYL ALCOHOL 
MYRISTYL LAURATE 
MYRISTYL ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
MENTHOL 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:10742-8476-11 TUBE (TUBE) in 1 BLISTER PACK
12 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/16/2012
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIOperations
The Mentholatum Company002105757MANUFACTURE

Revised: 06/2012
 
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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