ELTAMD UV SHIELD SPF45- zinc oxide and octinoxate sunscreen lotion 
CP Skin Health Group, Inc.

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EltaMD UV Shield SPF45

Warnings

For external use only Do not use on damaged or broken skin When using this product keep out of eyes Stop use and ask a physician if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients

Zinc Oxide 9.0%   Sunscreen

Octinoxate 7.5%   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 lest 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 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses children under 6 months: Ask a physician

Inactive Ingredients

Purified Water, Isopropyl Palmitate, Octyl Stearate, Cetearyl Alcohol, Polysorbate 60, Oleth-3 Phosphate, Phenoxyethanol, Cetearyl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Polyether-1, Butylene Glycol, PEG-7 Trimethylolpropane Coconut Ether, Tocopheryl Acetate, Citric Acid, Iodopropynyl Butylcarbamate, Triethoxycaprylylsilane

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Labeling

UV Shield UC

ELTAMD UV SHIELD SPF45 
zinc oxide and octinoxate sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2282
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION90 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)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTYL STEARATE (UNII: 772Y4UFC8B)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2282-385 g in 1 TUBE; Type 0: Not a Combination Product01/10/2018
2NDC:72043-2282-8198 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/201807/07/2022
3NDC:72043-2282-150 g in 1 TUBE; Type 0: Not a Combination Product04/20/2022
4NDC:72043-2282-010.5 g in 1 TUBE; Type 0: Not a Combination Product04/20/2022
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(72043-2282)

Revised: 11/2023
Document Id: f02d3f5a-a4cf-48fc-a5b6-8b6d0bd307f7
Set id: 7c49f971-d425-4be9-a665-5cd218b7f945
Version: 5
Effective Time: 20231109
 
CP Skin Health Group, Inc.