ELTAMD SKINCARE UV AOX ELEMENTS SPF50 TINTED- titanium dioxide, zinc oxide sunscreen lotion 
CP Skin Health Group, Inc

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EltaMD Skincare UV AOX Elements SPF50 Tinted

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.

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.

Purpose

Sunscreen

Active Ingredients

Titanium Dioxide 4.4%
Zinc Oxide 13.5%

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 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.

Other information:

Protect this product from excessive heat and direct sun.

QUESTIONS

call toll free 1-800-633-8872

Inactive ingredients

Water, Dimethicone, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, cetyl dimethicone, dimethicone PEG-10/15 crosspolymer,Polyhydroxystearic Acid, alumina, phenoxyethanol, iron oxides, Triethoxycaprylylsilane, sodium chloride, hydrogen dimethicone, sodium hyaluronate, potassium sorbate, Tocopheryl Acetate, tocopherol, bisabolol, carnosine, dipropylene glycol, ascorbyl palmitate, soidum citrate, canola oil, zingiber officinale (giner) root extract

Labeling

UV AOX Elements UC_Page_1

ELTAMD SKINCARE UV AOX ELEMENTS SPF50 TINTED 
titanium dioxide, zinc oxide sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2519
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE44 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION135 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROGEN DIMETHICONE (30 CST) (UNII: JF2ZJ6R2WD)  
HYALURONIC ACID (UNII: S270N0TRQY)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CARNOSINE (UNII: 8HO6PVN24W)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CANOLA OIL (UNII: 331KBJ17RK)  
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2519-148 g in 1 TUBE; Type 0: Not a Combination Product11/14/2023
2NDC:72043-2519-22 g in 1 PACKET; Type 0: Not a Combination Product11/14/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/14/2023
Labeler - CP Skin Health Group, Inc (611921669)
Registrant - CP Skin Health Group, Inc (611921669)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(72043-2519)

Revised: 11/2023
Document Id: 38625f9d-801a-4728-95fa-975ed85dd164
Set id: 2c74209d-9b88-4c32-ad42-cd6de16c1fef
Version: 1
Effective Time: 20231114
 
CP Skin Health Group, Inc