ELTAMD UV FACIAL SPF30 PLUS- zinc oxide and octinoxate sunscreen lotion

EltaMD UV Facial SPF30 Plus by

Drug Labeling and Warnings

EltaMD UV Facial SPF30 Plus 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. Rinse with warm water to remove Stop use and ask a physician if rash occurs If product is swallowed, get medical help or contact a Poison Control Center right away

Active ingredients

Octinoxate 7.5%   Sunscreen

Zinc Oxide 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. use a water-resistant sunscreen if swimming or sweating. reapply 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 another sun protection measures including: limit time in the sun, especially from 10 am - 2 pm wear long-sleeve shirts, pants, hats and sunglasses Children under 6 months: Ask a physician

Inactive Ingredients

purified water, petrolatum, isopropyl palmitate, octyl stearate, glyceryl stearate, cetearyl glucoside, dimethicone, PEG-100 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl tautrate copolymer, polyisobutene, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, tocopheryl acetate, ployether-1, citric acid, oleth-3 phosphate, phenoxyethanol, butylene glycol, iodopropynyl butylcarbamate, triethoxycaprylylsilane

UVFACIALUC

INGREDIENTS AND APPEARANCE

ELTAMD UV FACIAL SPF30 PLUS 
zinc oxide and octinoxate sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2283
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	70 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)
PETROLATUM (UNII: 4T6H12BN9U)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OCTYL STEARATE (UNII: 772Y4UFC8B)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2283-3	85 g in 1 TUBE; Type 0: Not a Combination Product	01/10/2018
2	NDC: 72043-2283-4	114 g in 1 JAR; 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(72043-2283)