COMPLETE MOISTURE- dimethicone, octinoxate, and octisalate stick

Complete Moisture by

Drug Labeling and Warnings

Complete Moisture by is a Otc medication manufactured, distributed, or labeled by Blistex Inc., 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

behenoyl stearic acid, caprylic/capric triglyceride, cholesteryl/behenyl/octyldodecyl lauroyl glutamate, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavor, glycerin, hydrogenated phosphatidylcholine, jojoba esters, microcrystalline wax, ozokerite, panthenol, petrolatum, phenoxyethanol, purified water, sodium borate, sodium saccharin, squalane

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

Blistex®
LIP PROTECTANT/SUNSCREEN

COMPLETE
MOISTURE®

Moisture Plus
Ultra-Hydrating Ingredients

Penetrates To Quench Dry Lips

Net Wt. .15 oz. (4.25 g)

SPF 15

A Surge Of
Moisture
Lips Can Feel

INGREDIENTS AND APPEARANCE

COMPLETE MOISTURE 
dimethicone, octinoxate, and octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1112
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
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PETROLATUM (UNII: 4T6H12BN9U)
CERESIN (UNII: Q1LS2UJO3A)
7-BEHENOYLSTEARIC ACID (UNII: P2T8BLD83C)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
SODIUM BORATE (UNII: 91MBZ8H3QO)
PANTHENOL (UNII: WV9CM0O67Z)
SQUALANE (UNII: GW89575KF9)
CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 07PS463G0H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1112-1	1 in 1 CARTON	05/08/2018	03/25/2020
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 10157-1112-2	2 in 1 CARTON	05/08/2018	03/25/2020
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	05/08/2018	03/25/2020

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-1112)