ELTAMD UV ACTIVE- zinc oxide, titanium dioxide sunscreen cream 
CP Skin Health Group, Inc.

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EltaMD UV Active

Warnings

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

Keep out of reach of children.

Keep out of reach of children.

Active Ingredients

Zinc Oxide   19.0%   Sunscreen

Titanium Dioxide   4.0%   Sunscreen

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.

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. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every two 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 sunscreen with a broad-spectrum SPF value of 15 or higher. Limit time in the sun, especially from 10 am to 2 pm. Wear long sleeved shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.

Questions

Questions or Comments?

1-800-633-8872

Other information

Protect this product from excessive heat and direct sun.

Inactive ingredients

water, caprylic/capric trigylceride, coco-caprylate/caprate, ethyl macadamiate, glycerin, sorbitan olivate, polyglyceryl-6 polyricinoleate, C15-19 alkane, hydrogenated polyisobutene, sodium chloride, triethoxycaprylylsilane, silica, glyceryl beheanate, hydroxyacetophenone, polyglyceryl-2 isostearate, polyhydroxysearic acid, disteardimonium hectorite, 1,2-hexanediol, caprylyl glycol, hydrolyzed jojoba esters, xanthan gum, diemthicone, sclerotium gum, trisodium ethylenediamine disuccinate, lecithin, pullulan, jojoba esters, polygonum aviculare extract, tocopherol, malic acid 

Labeling

UV Active UC 3oz Tube

ELTAMD UV ACTIVE 
zinc oxide, titanium dioxide sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION190 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE40 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
glycerin (UNII: PDC6A3C0OX)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MALIC ACID (UNII: 817L1N4CKP)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
C15-19 ALKANE (UNII: CI87N1IM01)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
ETHYLHEXYLGLYCERYL BEHENATE (UNII: JRY34LRD7B)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2600-390 g in 1 TUBE; Type 0: Not a Combination Product02/03/2020
2NDC:72043-2600-22 g in 1 PACKET; Type 0: Not a Combination Product08/24/2021
3NDC:72043-2600-8234 g in 1 TUBE; Type 0: Not a Combination Product07/06/202211/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/03/2020
Labeler - CP Skin Health Group, Inc. (611921669)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
CP Skin Health Group, Inc.080170933manufacture(72043-2600)

Revised: 11/2023
Document Id: 3c3c0d5a-342d-4a67-bed9-40dcd39f3869
Set id: 2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd2
Version: 4
Effective Time: 20231109
 
CP Skin Health Group, Inc.