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

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EltaMD UV Clear Tinted 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. If product is swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

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, nicacinamide, octyldodecyl neopentanoate, butylene glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyisobutene, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, tocopheryl acetate, lactic acid, oleth-3 phosphate, phenoxyethanol, iodopropynyl butylcarbamate, isopropyl palmitate, octyl stearate, iron oxides, triethoxycaprylylsilane

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Labeling

02520A UV Clear Tinted New Artwork

ELTAMD UV CLEAR TINTED SPF46 
zinc oxide and octinoxate sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2520
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)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
LACTIC ACID (UNII: 33X04XA5AT)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTYL STEARATE (UNII: 772Y4UFC8B)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2520-148 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
2NDC:72043-2520-22 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(72043-2520)

Revised: 11/2023
Document Id: e196f0db-f021-438a-b0d0-e33b1997546b
Set id: 1ac59ef1-113e-4ad1-90c3-38353bc7e1ec
Version: 5
Effective Time: 20231109
 
CP Skin Health Group, Inc.