ELTAMD UV SHEER- zinc oxide and octocrylene sunscreen cream

EltaMD UV Sheer by

Drug Labeling and Warnings

EltaMD UV Sheer 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. Rinse with 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

Octocrylene 10% Sunscreen
Zinc Oxide 15% Sunscreen

Uses

Helps prevent sunburn. If used as directed with other sun protection measure (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 measure (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

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, 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

Other Information

Protect this product from excessive heat and direct sun.

Inactive ingredients

water, butyloctyl salicylate, coco-caprylate/caprate, isohexadecane, butylene glycol, isododecane, phenoxyethanol, polyhydroxystearic acid, triethoxycaprylylsilane, polyacrylate crosspolymer-6, acacia Senegal gum, polysilicone-11, xanthan gum, tetrahexyldecyl ascorbate, ethylhexylglycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalene, disodium EDTA, polysorbate 60, sodium hyaluronate, sodium hydroxide

Questions?

Call toll free 1-800-633-8872

Labeling

INGREDIENTS AND APPEARANCE

ELTAMD UV SHEER 
zinc oxide and octocrylene sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2563
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	150 g  in 1000 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYALURONIC ACID (UNII: S270N0TRQY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISODODECANE (UNII: A8289P68Y2)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ACACIA SENEGAL FLOWER (UNII: 72P931MTC2)
XANTHAN GUM (UNII: TTV12P4NEE)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISOHEXADECANE (UNII: 918X1OUF1E)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2563-1	30 g in 1 TUBE; Type 0: Not a Combination Product	11/03/2020	11/09/2023
2	NDC: 72043-2563-7	50 g in 1 TUBE; Type 0: Not a Combination Product	11/03/2020
3	NDC: 72043-2563-0	10 g in 1 TUBE; Type 0: Not a Combination Product	11/03/2020
4	NDC: 72043-2563-2	2 g in 1 PACKET; Type 0: Not a Combination Product	11/03/2020	11/09/2023
5	NDC: 72043-2563-3	85 g in 1 TUBE; Type 0: Not a Combination Product	07/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/30/2020

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(72043-2563)