SOFT AND LUSH- dimethicone, octinoxate, and octisalate stick

Soft and Lush by

Drug Labeling and Warnings

Soft and Lush by is a Otc medication manufactured, distributed, or labeled by Blistex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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)

INGREDIENTS AND APPEARANCE

SOFT AND LUSH 
dimethicone, octinoxate, and octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	2 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	6.6 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	4.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1131-1	1 in 1 BLISTER PACK	08/01/2018
1		3.69 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 10157-1131-2	2 in 1 BLISTER PACK	08/01/2018
2		3.69 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2018

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-1131)