ELTAMD UV RESTORE- titanium dioxide, zinc oxide sunscreen lotion

Drug Labeling and Warnings

Drug Details [pdf]

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.

Indication

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.

Keep out of reach of children

Keep out of reach of children

Active Ingredients

Titanium Dioxide   2.0%

Zinc Oxide   15.0%

Purpose

Sunscreen   

Inactive Ingredients

water, coco-caprylate/caprate, butyloctyl salicylate, caprylic/capric triglyceride, octyldodecyl neopentanoate, methyl glucose sequistearate, silica, glyceryl stearate, PEG-100 stearate, PEG-20 methyl glucose sequistearate, Phenoxyethanol, triethocycaprylylsilane, polyhydroxysteric acid, glycerin, glyceryl behenate, saccharide isomerate, xanthan gum, zingber officinale (Ginger) root extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalane, dimethicone, ethylhexylglycerin, tetrahexyldocyl ascorbate, tocopheryl aceteate, sclerothum gum, lecithin, pullulan, polysorate 60, tocopherol, mica

Other Information

protect this product from excessive heat and direct sun

questions or comments

Call toll free 1-800-633-8872

Labeling

INGREDIENTS AND APPEARANCE

ELTAMD UV RESTORE 
titanium dioxide, zinc oxide sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72043-2631
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	150 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	20 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)
SILICA (UNII: ETJ7Z6XBU4)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
XANTHAN GUM (UNII: TTV12P4NEE)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SCLEROTIUM GUM (UNII: 2X51AD1X3T)
PULLULAN (UNII: 8ZQ0AYU1TT)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72043-2631-1	48 g in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/02/2026

Labeler - CP Skin Health Group, Inc (611921669)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72043-2631)