ELTAMD UV SHEER- zinc oxide and octocrylene sunscreen cream 
CP Skin Health Group, Inc.

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EltaMD UV Sheer

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

02536 Box- UC EltaMD UV Sheer 1.7oz PDF
ELTAMD UV SHEER 
zinc oxide and octocrylene sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2563
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 g  in 1000 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2563-130 g in 1 TUBE; Type 0: Not a Combination Product11/03/202011/09/2023
2NDC:72043-2563-750 g in 1 TUBE; Type 0: Not a Combination Product11/03/2020
3NDC:72043-2563-010 g in 1 TUBE; Type 0: Not a Combination Product11/03/2020
4NDC:72043-2563-22 g in 1 PACKET; Type 0: Not a Combination Product11/03/202011/09/2023
5NDC:72043-2563-385 g in 1 TUBE; Type 0: Not a Combination Product07/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/30/2020
Labeler - CP Skin Health Group, Inc. (611921669)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(72043-2563)

Revised: 12/2023
Document Id: 8a66097c-9f42-4c0c-abc4-dc22b27624b6
Set id: 2564e811-70f5-4d00-be8e-686b55e31630
Version: 5
Effective Time: 20231205
 
CP Skin Health Group, Inc.