ELTAMD UV PHYSICAL SPF41- zinc oxide and titanium dioxide sunscrreen lotion

EltaMD UV Physical SPF41 by

Drug Labeling and Warnings

EltaMD UV Physical SPF41 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 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

Zinc Oxide 9.0%   Sunscreen
Titanium Dioxide 7.0%   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 40 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

Alumina, Butylene Glycol, Citric Acid, Iodopropynyl Butylcarbamate, Iron Oxide, Isopropyl Palmitate, Lecithin, Linoleic Acid, Hydrogen Dimethicone, Octyl Stearate, Octyldodecyl Neopentanoate, Oleth-3 Phosphate, Perfluorononyl Dimethicone, Phenoxyethanol, Polyacrylate 13, Polyisobutene, Polysorbate 20, Purified Water, Quercitin, Sodium Hydroxide, Thioctic Acid, Triethoxycaprylylsilane

UVPHYSICALUC

INGREDIENTS AND APPEARANCE

ELTAMD UV PHYSICAL SPF41 
zinc oxide and titanium dioxide sunscrreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2578
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	90 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OCTYL STEARATE (UNII: 772Y4UFC8B)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
THIOCTIC ACID (UNII: 73Y7P0K73Y)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
QUERCETIN (UNII: 9IKM0I5T1E)
LINOLEIC ACID (UNII: 9KJL21T0QJ)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2578-3	85 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(72043-2578)