ELTAMD UV ELEMENTS SPF44- zinc oxide and titanium dioxide sunscreen lotion

EltaMD UV Elements SPF44 by

Drug Labeling and Warnings

EltaMD UV Elements SPF44 by is a Otc medication manufactured, distributed, or labeled by CP Skin Health Group, 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 suing this product keep out of eyes. Rinse with water to remove. Stop use and ask physician if rash occurs Keep out of reach of children. If product is swallowed contact a Poison Control Center right away.

Active Ingredients

Zinc Oxide 10.0% Sunscreen

Titanium Dioxide 5.5% Sunscreen

Uses

Helps prevent sunburn If used as directed withother sun protection measures (See Directions) decreases the risk of skin cancer and early skin aging caued by the sun.

Directions

Apply liberally 15 minutes before sun exposure Reapply after 40 minutes of swimming or sweating immedaitely after towel drying at least 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 in the sun, especially from 10a.m.-2p.m. wear long-sleeve shirts, pants, hats and sunglasses Children under 6 months: Ask a physician

Inactive Ingredients

purified water, cyclopentasiloxane, dimethicone, octyldodecyl neopentanoate, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, dimethicone/PEG-10/15 crosspolymer, sodium hyaluronate, asorbyl palmitate, tocopherol, sodium chloride, triethoxycaprylylsilane, alumina, methicone, potassium sorbate, phenoxyethanol, citric acid, iron oxides

UVELEMENTSUC

INGREDIENTS AND APPEARANCE

ELTAMD UV ELEMENTS SPF44 
zinc oxide and titanium dioxide sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2512
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	55 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2512-2	57 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(72043-2512)