ELTAMD UV LUMINOUS- titanium dioxide, zinc oxide sunscreen lotion 
CP Skin Health Group, Inc

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EltaMD UV Luminous

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.

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.

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply 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.

Keep out of reach of children

Keep out of reach of children

Active Ingredients

Titanium Dioxide 7.2% Sunscreen
Zinc Oxide 9.0% Sunscreen

Other information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients

water, isopropyl palmitate, ethylhexyl stearate, octyldodecyl neopentanoate, perfluorononly dimethicone, alumina, polyacrylate-13, phenoxyethanol, hydrogen dimethicone, polyisobutene, triethoxycaprylylsilane, oleth-3 phosphate, citric acid, polysorbate 20, sorbitan isostearate, sodium hydroxide, thioctic acid, quercetin, tocopherol, iron oxides

Questions?

Call toll free 1-800-633-8872

Labeling

UV Luminous UC

ELTAMD UV LUMINOUS 
titanium dioxide, zinc oxide sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2256
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE72 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION90 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTYL STEARATE (UNII: 772Y4UFC8B)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y)  
QUERCETIN (UNII: 9IKM0I5T1E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2256-110 g in 1 TUBE; Type 0: Not a Combination Product12/09/202011/14/2023
2NDC:72043-2256-748 g in 1 TUBE; Type 0: Not a Combination Product12/09/2020
3NDC:72043-2256-330 g in 1 TUBE; Type 0: Not a Combination Product12/09/202011/14/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/09/2020
Labeler - CP Skin Health Group, Inc (611921669)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(72043-2256)

Revised: 11/2023
Document Id: 4a5f8f4a-27b8-47d6-8d7c-3e6a67094bab
Set id: 96988ebe-c489-4d76-9e49-0d94aec5be0c
Version: 4
Effective Time: 20231114
 
CP Skin Health Group, Inc