ELTAMD UV CLEAR SPF46- zinc oxide and octinoxate sunscreen lotion 
CP Skin Health Group, Inc.

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EltaMD UV Clear SPF46

Warnings

For external use only Do not use on damaged or broken skin When using the product keep out of eyes. Rinse with water to remove 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 to face and neck 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 a.m.- 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses children under 6 months: Ask a physician

Inactive Ingredients

Purified water, Cyclopentasiloxane, Niacinamide, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Sodium Hyaluronate, Tocopheryl Acetate, Lactic Acid, Oleth-3 Phosphate, Phenoxyethanol, Butylene Glycol, Iodopropynyl Butylcarbamate, Triethoxycaprylylsilane

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Labeling

RM8518 Box UC UV Clear 1.7oz

ELTAMD UV CLEAR SPF46 
zinc oxide and octinoxate sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2500
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
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
LACTIC ACID (UNII: 33X04XA5AT)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
OCTYLDODECYL BENZOATE (UNII: R04N7AS5EA)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
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:72043-2500-148 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
2NDC:72043-2500-514 g in 1 BOTTLE; Type 0: Not a Combination Product12/17/2020
3NDC:72043-2500-22 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(72043-2500)

Revised: 11/2023
Document Id: b9a47572-3530-4051-8644-5656accda6d3
Set id: 60438ec5-0b1f-45fd-8ce4-debfdbdc6721
Version: 7
Effective Time: 20231109
 
CP Skin Health Group, Inc.