ELTAMD UV LIP BALM SPF31- zinc oxide and octinoxate sunscreen lotion

EltaMD UV Lip Balm SPF31 by

Drug Labeling and Warnings

EltaMD UV Lip Balm SPF31 by is a Otc medication manufactured, distributed, or labeled by CP Skin Health, Inc, Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only Do not use on damaged or broken skin When using this product keep out of eyes Stop use and ask a physician if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients

Octinoxate 7.5% Sunscreen

Zinc Oxide 9.0% Sunscreen

Uses

Helps prevent sunburn if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Directions

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at lest every 2 hours Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time int he sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses children under 6 months: Ask a physician

Inactive Ingredients

Petrolatum, Ricinus Communis (Castor) Seed Oil, Cetearyl Alcohol, Lauryl Laurate, Purified Water, Flavor, Polyethylene, Hydrogenated Castor Oil, Olea Europaea (Olive) Fruit Oil, Cera Alba, Glycerin, Copernicia Cerifera (Carnauba) Wax, Glyceryl Behenate, Microcrystalline Wax, Quercetin, Thiotic Acid, Ascorbyl Palmitate, Tocopheryl Acetate, Euphorbia Cerifera (Candelilla) Wax, Hydrogenated Soybean Oil, Hydrolyzed Caesalpinia Spinosa Gum, Glyceryl Stearate, Caesalpinia Spinosa Gum

UVLIPBALMUC

INGREDIENTS AND APPEARANCE

ELTAMD UV LIP BALM SPF31 
zinc oxide and octinoxate sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2510
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
CASTOR OIL (UNII: D5340Y2I9G)
LAURYL LAURATE (UNII: GPW77G0937)
OLIVE OIL (UNII: 6UYK2W1W1E)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
WHITE WAX (UNII: 7G1J5DA97F)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
THIOCTIC ACID (UNII: 73Y7P0K73Y)
QUERCETIN (UNII: 9IKM0I5T1E)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2510-8	8 g in 1 TUBE; Type 0: Not a Combination Product	01/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/10/2018

Labeler - EltaMD, Inc. (611921669)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72043-2510)