ELTAMD UV REPLENISH BROAD SPECTRUM SPF44- zinc oxide, titanium dioxide lotion 
CP Skin Health Group, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

EltaMD UV Replenish Broad Spectrum SPF44

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.  Rinse with water to remove

Stop use and ask 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

Keep out of reach of children

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

Active Ingredients

Zinc Oxide   10.0%

Titanium Dioxide   5.5%

Directions

Apply liberally 15 minutes before sun exposure

reapply: after 40 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, regularyly 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 uner 6 months: ask a physician

Inactive Ingredients

purified water, caprylic/capric triglyceride, C15-19 Alkane, Octyldodecyl neopentanoate, butyloctyl salicylate, cetyl dimethicone, hydrogenated polyisobutene, Mica, dimethicone, sorbitan olivate, polyglyceryl-6 polyricinoleate, polyhydroxystearic acid, sodium chloride, phenoxyethanol, polyglyceryl-2 isostearate, disteardimonium hectorite, glycerin, xanthan gum, triethoxycaprylylsilane, euphorbia cerifera (Candelilla) wax, sodium hyaluronate, disodium EDTA, ethylhexyl glycerin, glyceryl behenate, silica, ascorbyl palmitate, tocopheryl acetate

Questions or Comments

call toll free 1-800-633-8872

Other information

Protect this product from excessive heat and direct sun

Labeling

UV Replenish UC

ELTAMD UV REPLENISH BROAD SPECTRUM SPF44 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2514
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION100 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE55 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
C15-19 ALKANE (UNII: CI87N1IM01)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
MICA (UNII: V8A1AW0880)  
dimethicone (UNII: 92RU3N3Y1O)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CANDELILLA WAX (UNII: WL0328HX19)  
HYALURONIC ACID (UNII: S270N0TRQY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72043-2514-257 g in 1 TUBE; Type 0: Not a Combination Product07/26/201809/11/2023
2NDC:72043-2514-12 g in 1 PACKET; Type 0: Not a Combination Product07/07/202209/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/26/201809/11/2023
Labeler - CP Skin Health Group, Inc. (611921669)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(72043-2514)

Revised: 9/2023
 
CP Skin Health Group, Inc.