ELTAMD UV PURE SPF47- zinc oxide and titanium dioxide sunscreen cream 
CP Skin Health Group, Inc.

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EltaMD UV Pure SPF47

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 Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients

Zinc Oxide 10.0% Sunscreen

Titanium Dioxide 5.5% Sunscreen

Uses

helps prevents 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 prevents 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 Reapply after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time int he sun increases your risk of skin cancer and early skin aging. To decrease this risk, egularly 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 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses Children under 6 months: Ask a physician.

Inactive Ingredients

Purified Water, Cyclopentasiloxane, Dimethicone, Octyldodecyl neopentanoate, laury PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Ascorbyl Palmitate, Tocopherol, Sodium Chloride, Triethoxycaprylylsilane, Alumina, Hydrogen Dimethicone, Potassium Sorbate, Citric Acid

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Labeling

UV Pure Unit Carton artwork_Page_1

ELTAMD UV PURE SPF47 
zinc oxide and titanium dioxide sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2582
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION100 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE55 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2582-4114 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
2NDC:72043-2582-22 g in 1 PACKET; Type 0: Not a Combination Product07/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/10/2018
Labeler - CP Skin Health Group, Inc. (611921669)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(72043-2582)

Revised: 3/2024
Document Id: 6f7bbffb-97bc-4a8e-aba3-dbd9bd1ef381
Set id: 9afe900b-4186-4189-a871-ad6f26fc26e4
Version: 5
Effective Time: 20240327
 
CP Skin Health Group, Inc.