ELTAMD UV AOX MIST- zinc oxide sunscreen spray

EltaMD UV AOX Mist by

Drug Labeling and Warnings

EltaMD UV AOX Mist 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

Stop use and ask a doctor if rash occurs

When using this product: keep out of eyes, rinse with water to remove.  Do not puncture or incinerate.  Contents under pressure.  Do not store at temperatures above 120F

Active Ingredient

Zinc Oxide   14.0%       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.

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. Hold container 4-6 inches from the skin to apply.  Do not spray product directly into face, spray on hands then apply to face.  do not apply in windy conditions.  Use in a well-ventilated area and avoide inhallation.  Reapply after 40 mintues of swimming or sweating, immediately after towel drying and 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 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Inactive Ingredients

water, octyldodecyl neopentanoate, C15-19 alkane, butyloctyl salicylate, coco-caprylate/caprate, polyhydroxystearic acid, cetearyl alcohol, phenoxyethanol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, triethoxycaprylylsilane, coco-glucoside, aloe barbadensis leaf juice, tocopheryl acetate, isohexadecane, scloerolium gum, glycerin, cocos nucifer (coconut) fruit extract, ethylhexylglycerin, tetrahexyldecyl ascorbate, polysorbate 60, sorbitan isostearate

Keep out of reach of children

Keep out of reach of children

Questions

Questions or Comments?

Call toll free 1-800-633-8872

Other Information

protect this product from excessive heat and direct sun

Labeling

INGREDIENTS AND APPEARANCE

ELTAMD UV AOX MIST 
zinc oxide sunscreen spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2671
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	14.0 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
C15-19 ALKANE (UNII: CI87N1IM01)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO GLUCOSIDE (UNII: ICS790225B)
BETASIZOFIRAN (UNII: 2X51AD1X3T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2671-5	1 in 1 CARTON	03/31/2023
1		141 g in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/31/2023

Labeler - CP Skin Health Group, Inc (611921669)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72043-2671)