ELTAMD UV AERO- zinc oxide and octinoxate sunscreen aerosol

EltaMD UV Aero by

Drug Labeling and Warnings

EltaMD UV Aero 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; not to be swallowed

Do not use on damaged or broken skin

When using this product keep out of eyes

Avoid spraying into eyes or onto other mucous membranes. Rinse with water to remove.

Stop use and ask physician if signs of irritation or rash appear

If product is swallowed, get medical help or contact a Poison Control Center right away.

DANGER EXTREMELY FLAMMABLE. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120F (49C). Use only as directed. Intentional misure by deliberately concentrating and inhaling the contents can be harmful or fatal. Hard surfaces may become damp when product is sprayed. Avoid slips or falls.

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.

Keep out of reach of children

Keep out of reach of children

Active ingredients

Zinc Oxide 9.0% Sunscreen

Octinoxate 7.5% Sunscreen

Directions

SHAKE WELL before each use

apply liberally 15 minutes before sun exposure

do not apply in windy conditions

hold can (upright or inverted) 4 to 6 inches away from body and apply liberally, spraying slowly and evenly until product is visible on skin.

gently rub in

do not spray into face. Spray into hand and apply to the face.

use in well-ventilated areas

reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

Sun Protection Measures:

Spending time int eh sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection meausres including:

limit time in the sun, epsecially from 10 am - 2 pm

wear long-sleeve shirts, pants, hats and sunglasses

children under 6 months: Ask a physician

Inactive Ingredients

butylene glycol, capryloyl glycine, cyclopentasiloxane, dimethicone, dimethicone/PEG-10/15 crosspolymer, dimethidcone/vinyl diemthicone crosspolymer, isobutane, lauryl PEG-9 polymethylsiloxyethyl diemthicone, phenoxyethanol, propane, purified water, sodium chloride, triethoxycaprylylsilane, undecylenoyl glycine

UVAEROUC.jpg

INGREDIENTS AND APPEARANCE

ELTAMD UV AERO 
zinc oxide and octinoxate sunscreen aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2587
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	93 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ISOBUTANE (UNII: BXR49TP611)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANE (UNII: T75W9911L6)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2587-6	170 g in 1 CAN; 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(72043-2587)