UV DAILY DEEP TINT- octinoxate, zinc oxide sunscreen lotion 
CP Skin Health Group, Inc.

----------

EltaMD UV Daily Deep Tint

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.

Keep out of reach of children

Keep out of reach of children

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.

Active Ingredients

Octinoxate    7.5%

Zinc Oxide   9.0%

Inactive Ingredients

water, petrolatum, isopropyl palmitate, dimethicone, cetearyl alcohol, oleth-3 phosphate, phenoxyethanol, octyldodecyl neopentanoate, ethylhexyl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyisobutene, cetearyl glucoside, polyether-1, butylene glycol, PEG-7 trimethylolpropane cocnut ether, sodium hyaluronate, citric acid, iodopropynyl butylcarbamate, tocopheryl acetate, triethoxycaprylylsilane, iorn oxides

Questions

Call toll free 1-800-633-8872

Labeling

UV Daily Deep Tint UC

UV DAILY DEEP TINT 
octinoxate, zinc oxide sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2920
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE750 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION900 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PETROLATUM (UNII: 4T6H12BN9U)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYALURONIC ACID (UNII: S270N0TRQY)  
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2920-150 g in 1 BOTTLE; Type 0: Not a Combination Product05/09/2024
2NDC:72043-2920-22 g in 1 PACKET; Type 0: Not a Combination Product05/09/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/09/2024
Labeler - CP Skin Health Group, Inc. (611921669)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(72043-2920)

Revised: 5/2024
Document Id: 79386a40-776e-47d1-8909-88776673d1a9
Set id: c12fa9a4-d7e5-46bf-9bfb-1cbbaa73b450
Version: 1
Effective Time: 20240509
 
CP Skin Health Group, Inc.