SOFTLIPS  PEARL PLUS VANILLA- dimethicone, octinoxate, octisalate, oxybenzone 
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.

----------

SOFTLIPS PEARL PLUS VANILLA

Softlips Pearl

Drug Facts

Active ingredient

Octinoxate 7.5%

Octisalate 5%

Purpose

Octinoxate – Sunscreen

Octisalate - Sunscreen

Uses

Warnings

Skin Cancer/Skin Agent 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.

Dosage and Administration

Other information

Inactive ingredients

lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecane copolymer, mineral oil, bis-diglycerl polyacyladipate-2, oleyl alcohol, copernicia cerifera (carnauba) wax, ricinus communis (castor) seed oil, cetyl lactate, polyethylene, paraffin, ammonium glycyrrhizate, BHT, flavor, magnesium stearate, menthol, tocopheryl acetate [vitamin E], bismuth oxychloride, carmine, mica, titanium dioxide

Questions or comments?

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Softlips.com

Softlips Vanilla

Drug Facts

Active Ingredient

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Purpose

Dimethicone – Skin protectant

Octinoxate – Sunscreen

Octisalate – Sunscreen

Oxybenzone - Sunscreen

Uses

Warnings

Skin Cancer/Skin Agent 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.

Dosage and Administration

Other information

Inactive ingredients

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

Questions or comments?

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Softlips.com

Principal Display Panel

Front Blistercard

Principal Display Panel

Back Blistercard
SOFTLIPS   PEARL PLUS VANILLA
dimethicone, octinoxate, octisalate, oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-7011
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-7011-11 in 1 PACKAGE; Type 0: Not a Combination Product01/02/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CYLINDER 1 g
Part 21 CYLINDER 1 g
Part 1 of 2
SOFTLIPS   PEARL
octinoxate, octisalate stick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN OIL (UNII: OVV5IIJ58F)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
CERESIN (UNII: Q1LS2UJO3A)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
MINERAL OIL (UNII: T5L8T28FGP)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CASTOR OIL (UNII: D5340Y2I9G)  
CETYL LACTATE (UNII: A7EVH2RK4O)  
PARAFFIN (UNII: I9O0E3H2ZE)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
CARMINIC ACID (UNII: CID8Z8N95N)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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 finalpart35202/01/2010
Part 2 of 2
SOFTLIPS   VANILLA
dimethicone, octinoxate, octisalate, oxybenzone stick
Product Information
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
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 finalpart35211/19/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/02/2017
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757manufacture(10742-7011)

Revised: 2/2023
Document Id: f4216d8c-6c0a-8d9a-e053-2a95a90ac1e6
Set id: 107bcaa9-4347-4979-be44-35183a9ee67e
Version: 2
Effective Time: 20230207
 
The Mentholatum Company