Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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SOFTLIPS VANILLA- dimethicone, octinoxate, octisalate, oxybenzone ointment 
The Mentholatum Company

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.

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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 prevent sunburn
  • temporarily protects chapped or cracked lips

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 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

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
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor

Other information

  • protect this product from excessive heat and direct sun

Inactive ingredients

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

Questions?

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

Principal Display Panel

Softlips Vanilla

Principal Display Panel

Drug Facts
SOFTLIPS  VANILLA
dimethicone, octinoxate, octisalate, oxybenzone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10742-3051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CERESIN (UNII: Q1LS2UJO3A)  
SQUALANE (UNII: GW89575KF9)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PETROLATUM (UNII: 4T6H12BN9U)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
MYRISTYL LACTATE (UNII: 1D822OC34X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MYRISTYL LAURATE (UNII: 58U0NZN2BT)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10742-3051-11 in 1 BLISTER PACK11/19/1997
12 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 10742-3051-92 in 1 BLISTER PACK11/19/1997
22 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 10742-3051-22 g in 1 TUBE; Type 0: Not a Combination Product11/19/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/19/1997
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757MANUFACTURE(10742-3051)

Revised: 12/2016
 
The Mentholatum Company


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