Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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SOFTLIPS WATERMELON- 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 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

Softlips Watermelon

Principal Display Panel

Drug Facts
SOFTLIPS  WATERMELON
dimethicone, octinoxate, octisalate, oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10742-8476
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 ug  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: 10742-8476-11 in 1 BLISTER PACK04/16/2012
12 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 10742-8476-22 in 1 BLISTER PACK12/01/2016
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 finalpart35204/16/2012
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757MANUFACTURE(10742-8476)

Revised: 12/2016
 
The Mentholatum Company


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