ELTAMD UV RESTORE TINTED- titanium dioxide and zinc oxide sunscreen lotion 
CP Skin Health Group, Inc.

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EltaMD UV Restore Tinted

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 a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Active Ingredients

Titanium Dioxide 2.0% Sunscreen
Zinc Oxide 15.0% Sunscreen

Keep out of reach of children

Keep out of reach of children

Uses

Helps prevent sunburn. If used as directed with other sun protection measure (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 measure (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 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

water, coco-caprylate/caprate, butyloctyl salicylate, octyldodecyl neopentanoate, caprylic/capric triglyceride, methyl glucose sesquistearate, silica, glyceryl stearate, PEG-100 stearate, PEG-20 methyl glycose sesquisterate, phenoxyethanol, triethoxycaprylylsilane, polyhydroxystearic acid, glycerin, saccharide isomerate, glyceryl behenate, xanthan gum, zingiber officiale (ginger) root extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalene, ethylhexylglycerin, tocopheryl acetate, sclerotium gum, lecithin, pulluan, dimethicone, polysorbate 60, ethylene/methacrylate copolymer, mica, iron oxides

Questions?

Call toll free 1-800-633-8872

Labeling

UV Restore Tinted_Page_1

ELTAMD UV RESTORE TINTED 
titanium dioxide and zinc oxide sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2640
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ZINGIBER CASSUMUNAR ROOT (UNII: 3NG517NPD8)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
SQUALANE (UNII: GW89575KF9)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
MICA (UNII: V8A1AW0880)  
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:72043-2640-257 g in 1 TUBE; Type 0: Not a Combination Product09/15/2020
2NDC:72043-2640-42 g in 1 PACKET; Type 0: Not a Combination Product09/15/2020
3NDC:72043-2640-114 g in 1 BOTTLE; Type 0: Not a Combination Product07/07/2022
4NDC:72043-2640-348 g in 1 BOTTLE; Type 0: Not a Combination Product06/10/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/15/2020
Labeler - CP Skin Health Group, Inc. (611921669)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(72043-2640)

Revised: 6/2024
Document Id: 2bc1d6c0-6ee3-48ed-b49f-4f4b17fb3ac4
Set id: 6a48ad0d-20e4-44b1-90d6-30bfbc68a152
Version: 6
Effective Time: 20240610
 
CP Skin Health Group, Inc.