ELTAMD UV SHIELD SPF45- zinc oxide and octinoxate sunscreen lotion

EltaMD UV Shield SPF45 by

Drug Labeling and Warnings

EltaMD UV Shield SPF45 by is a Otc medication manufactured, distributed, or labeled by EltaMD, 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

Octinoxate 7.5%   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. Use a water-resistant sunscreen if swimming or sweating. reapply 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 in the 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

Purified Water, Isopropyl Palmitate, Octyl Stearate, Cetearyl Alcohol, Polysorbate 60, Oleth-3 Phosphate, Phenoxyethanol, Cetearyl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Polyether-1, Butylene Glycol, PEG-7 Trimethylolpropane Coconut Ether, Tocopheryl Acetate, Citric Acid, Iodopropynyl Butylcarbamate, Triethoxycaprylylsilane

UVSHIELDUC

INGREDIENTS AND APPEARANCE

ELTAMD UV SHIELD SPF45 
zinc oxide and octinoxate sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2282
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OCTYL STEARATE (UNII: 772Y4UFC8B)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2282-3	85 g in 1 TUBE; Type 0: Not a Combination Product	01/10/2018
2	NDC: 72043-2282-8	198 g in 1 BOTTLE; 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(72043-2282)