Drug labels

EltaMD UV Restore

TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN · CP Skin Health Group, Inc · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
37fee381-ce6b-4949-9a4a-778aa839fb84
ID
d0f9434f-9396-4f8c-a985-b0296bff76f1
Effective time
20260806
Version
6
SPL product data elements

EltaMD UV Restore titanium dioxide, zinc oxide sunscreen TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION PHENOXYETHANOL ETHYLHEXYLGLYCERIN WATER OCTYLDODECYL NEOPENTANOATE TETRAHEXYLDECYL ASCORBATE BUTYLOCTYL SALICYLATE POLYHYDROXYSTEARIC ACID (2300 MW) TRIETHOXYCAPRYLYLSILANE GLYCERYL STEARATE SE PEG-100 STEARATE METHYL GLUCOSE SESQUISTEARATE PEG-20 METHYL GLUCOSE SESQUISTEARATE GLYCERIN SACCHARIDE ISOMERATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) SQUALANE POLYSORBATE 60 XANTHAN GUM LECITHIN, SOYBEAN PULLULAN BETASIZOFIRAN SILICON DIOXIDE DIMETHICONE CITRIC ACID MONOHYDRATE SODIUM CITRATE MEDIUM-CHAIN TRIGLYCERIDES .ALPHA.-TOCOPHEROL ACETATE GLYCERYL MONOBEHENATE MICA ISOPROPYL TITANIUM TRIISOSTEARATE GINGER

Warnings

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 ingredient
Active Ingredients Titanium Dioxide 2.0% Sunscreen Zinc Oxide 15.0% Sunscreen
Indications and usage

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.

Purpose

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.

Keep out of reach of children
Keep out of reach of children Keep out of reach of children
Dosage and administration

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 safety information
Other Information Protect this product from excessive heat and direct sun.
Inactive ingredient

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

Questions
Questions Call toll free 1-800-633-8872
Package label principal display panel
Labeling UV Restore Artwork
Harmonized identifiers (openFDA)
Application number
M020
Brand name
EltaMD UV Restore
Generic name
TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN
Manufacturer name
CP Skin Health Group, Inc
Product NDC
72043-2630
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
TITANIUM DIOXIDE, ZINC OXIDE
SPL ID
d0f9434f-9396-4f8c-a985-b0296bff76f1
SPL set ID
37fee381-ce6b-4949-9a4a-778aa839fb84
Package NDC
72043-2630-4, 72043-2630-2, 72043-2630-5, 72043-2630-1
Is original packager
true
UNII
15FIX9V2JP, SOI2LOH54Z
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.