ELTAMD UV SPF35- octinoxate, zinc oxide sunscreen lotion 
CP Skin Health Group, Inc

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EltaMD UV SPF35

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

Octinoxate 7.5% Sunscreen
Zinc Oxide 9.0% Sunscreen

Indications & 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.

Indications & 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. 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.

Other information:

Protect this product from excessive heat and direct sun.

Inactive ingredients

water, petrolatum, isopropyl palmitate, ethylhexyl stearate, dimethicone, phenoxyethanol, glyceryl stearate, PEG-100 stearate, oleth-3 phosphate, cetearyl alcohol, cetearyl glucoside, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyisobutene, polyether-1, ethylhexylglycerin, PEG-7 trimethylolpropane coconut ether, citric acid, tocopheryl acetate, sodium hyaluronate, triethoxycaprylylsilane

Questions?

Call toll free 1-800-633-8872

Labeling

UV Lotion UC 02291A

ELTAMD UV SPF35 
octinoxate, zinc oxide sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-6808
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION70 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PETROLATUM (UNII: 4T6H12BN9U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTYL STEARATE (UNII: 772Y4UFC8B)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYALURONIC ACID (UNII: S270N0TRQY)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-6808-8226 g in 1 TUBE; Type 0: Not a Combination Product05/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/31/2024
Labeler - CP Skin Health Group, Inc (611921669)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(72043-6808)

Revised: 5/2024
Document Id: 82fcbfc7-152a-4358-a4a8-20cfa0b9acef
Set id: 3029d6ed-a60b-4789-a567-d09b12d76bf4
Version: 1
Effective Time: 20240531
 
CP Skin Health Group, Inc