Eltamd Uv Restore

Eltamd Uv Restore
SPL v5
SPL
SPL Set ID 37fee381-ce6b-4949-9a4a-778aa839fb84
Route
TOPICAL
Published
Effective Date 2023-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (20 g) Zinc Cation (150 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01

Description

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.


Medication Information

Description

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.

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.

Labeling

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.

Questions

Call toll free 1-800-633-8872

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.

Active Ingredients

Titanium Dioxide 2.0% Sunscreen

Zinc Oxide 15.0% Sunscreen

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

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

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.

Labeling

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.

Questions

Call toll free 1-800-633-8872

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.

Active Ingredients

Titanium Dioxide 2.0% Sunscreen

Zinc Oxide 15.0% Sunscreen

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

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)