TLC- dimethicone, homosalate, and octisalate stick

TLC by

Drug Labeling and Warnings

TLC 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
Homosalate 8.0% (w/w)	Sunscreen
Octisalate 4.0% (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, avena sativa kernel flour, beeswax, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, cetyl dimethicone, chamomilla recutita (matricaria) flower extract, euphorbia cerifera (candelilla) wax, flavors, glyceryl stearate, gossypium herbaceum (cotton) extract, jojoba esters, lanolin, myristyl myristate, octyldodecanol, olea europaea (olive) fruit oil, phenoxyethanol, polyhydroxystearic acid, ricinus communis (castor) seed oil, saccharin, stearic acid, titanium dioxide, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

Blistex®
LIP PROTECTANT/SUNSCREEN

TLC

Shea Butter, Chamomile
& Cotton Extracts

Hydrates, Pampers
& Protects

New!

Net Wt. .15 oz. (4.25 g)
SPF 15

Tender
Loving Care
For Lips

INGREDIENTS AND APPEARANCE

TLC 
dimethicone, homosalate, and octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1158
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CASTOR OIL (UNII: D5340Y2I9G)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
OLIVE OIL (UNII: 6UYK2W1W1E)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
GOSSYPIUM HERBACEUM SEED RESIN (UNII: X408487D9E)
OAT BRAN (UNII: KQX236OK4U)
SHEA BUTTER (UNII: K49155WL9Y)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SACCHARIN (UNII: FST467XS7D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1158-1	1 in 1 CARTON	07/01/2019
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 10157-1158-2	2 in 1 CARTON	07/01/2019
2		4.25 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	07/01/2019

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-1158)