SOFTLIPS PEPPERMINT- dimethicone, octinoxate, octisalate, oxybenzone stick 
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

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

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

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

Directions

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 acetate [vitamin E]

Questions?

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

Package/Label Principal Display Panel

Softlips Peppermint

Principal Display Panel

Drug Facts
SOFTLIPS PEPPERMINT 
dimethicone, octinoxate, octisalate, oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8517
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 ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8517-12 in 1 BLISTER PACK11/07/2016
12 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/07/2016
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757manufacture(10742-8517)

Revised: 2/2023
Document Id: f421a647-b0f9-5ea4-e053-2995a90a3d88
Set id: 1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb27
Version: 2
Effective Time: 20230207
 
The Mentholatum Company