SOFT AND LUSH- dimethicone, octinoxate, and octisalate stick 
Blistex Inc.

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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Soft and Lush®

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 6.6% (w/w)Sunscreen
Octisalate 4.4% (w/w)Sunscreen

Uses

  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn

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 help 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

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

Other information

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, C12-15 alkyl benzoate, caprylic/capric triglyceride, ceramide NG, ceresin, cetyl dimethicone, cetyl palmitate, flavors, glyceryl laurate, hydrogenated castor oil, hydrogenated polyisobutene, jojoba esters, microcrystalline wax, palmitoyl hexapeptide-12, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, stearic acid, titanium dioxide, tribehenin

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®

Soft
&
Lush®

Creamy Smooth Texture
For Supple, Kissable Lips

Ceramide-Enhanced Formula
Softens & Conditions

SPF 15

Net Wt. 0.13 oz. (3.69 g)

Principal Display Panel - 3.69 g Cylinder Blister Pack
SOFT AND LUSH 
dimethicone, octinoxate, and octisalate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1131
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.6 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate4.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
CERESIN (UNII: Q1LS2UJO3A)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
WHITE WAX (UNII: 7G1J5DA97F)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
GLYCERYL LAURATE (UNII: Y98611C087)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
CERAMIDE NG (UNII: C04977SRJ5)  
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SACCHARIN (UNII: FST467XS7D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-1131-11 in 1 BLISTER PACK08/01/201807/08/2020
13.69 g in 1 CYLINDER; Type 0: Not a Combination Product
2NDC:10157-1131-22 in 1 BLISTER PACK08/01/201807/08/2020
23.69 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/201807/08/2020
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-1131)

Revised: 7/2020
Document Id: 1a2ce563-23ca-4550-a9de-7cf9c121d0c3
Set id: e999401e-2bd3-4e50-9a15-d89068129c04
Version: 3
Effective Time: 20200710
 
Blistex Inc.