SOFTLIPS  RASPBERRY- 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

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

Inactive ingredients

ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, cetyl alcohol, myristyl laurate, flavor, myristyl alcohol, BHT, camellia sinensis (green tea) leaf extract, carthamus tinctorius (safflower) seed oil, menthol, oenothera biennis (evening primrose) oil, punica granatum (pomegranate) seed extract, tocopheryl acetate [vitamin E]

Questions?

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

Package/Label Principal Display Panel

Softlips Raspberry

Package/Label Principal Display Panel

Drug Facts
SOFTLIPS   RASPBERRY
dimethicone, octinoxate, octisalate, oxybenzone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8470
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)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
POMEGRANATE SEED (UNII: 7294Z34NS7)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8470-11 in 1 BLISTER PACK01/12/2007
12 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10742-8470-92 in 1 BLISTER PACK01/12/2007
22 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/12/2007
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757manufacture(10742-8470)

Revised: 2/2023
Document Id: f42186e9-98ae-5c9d-e053-2995a90a00d1
Set id: d18b4c19-0365-44ec-bea8-4328e537e0d8
Version: 4
Effective Time: 20230207
 
The Mentholatum Company