ELTAMD UV FACIAL SPF30 PLUS- zinc oxide and octinoxate sunscreen lotion 
CP Skin Health Group, Inc.

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EltaMD UV Facial SPF30+

Warnings

For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with warm 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 7.0%   Sunscreen

Uses

Helps prevent 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 prevent 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. 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 another sun protection measures including: limit time in the sun, especially from 10 am - 2 pm wear long-sleeve shirts, pants, hats and sunglasses Children under 6 months: Ask a physician

Inactive Ingredients

purified water, petrolatum, isopropyl palmitate, octyl stearate, glyceryl stearate, cetearyl glucoside, dimethicone, PEG-100 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl tautrate copolymer, polyisobutene, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, tocopheryl acetate, ployether-1, citric acid, oleth-3 phosphate, phenoxyethanol, butylene glycol, iodopropynyl butylcarbamate, triethoxycaprylylsilane

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Labeling

UV Facial UC_Page_1
ELTAMD UV FACIAL SPF30 PLUS 
zinc oxide and octinoxate sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2283
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)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
PETROLATUM (UNII: 4T6H12BN9U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTYL STEARATE (UNII: 772Y4UFC8B)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2283-385 g in 1 TUBE; Type 0: Not a Combination Product01/10/2018
2NDC:72043-2283-4114 g in 1 JAR; Type 0: Not a Combination Product01/10/201809/11/2023
3NDC:72043-2283-22 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(72043-2283)

Revised: 11/2023
Document Id: e2128d85-4b31-4aa8-b9cc-8f15d61f6b34
Set id: 8426b0a0-ecd6-4486-b2da-57a950b46dc5
Version: 6
Effective Time: 20231130
 
CP Skin Health Group, Inc.