Drug labels

ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 50 (Light)

TITANIUM DIOXIDE, ZINC OXIDE · ZO Skin Health Inc. · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
4f8756bf-5b0d-5269-e063-6294a90ae6dc
ID
5ce2351f-a4f8-37f8-e063-6294a90aa116
Effective time
20261002
Version
3
SPL product data elements

ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 50 (Light) Titanium Dioxide, Zinc Oxide ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER PEG-10 DIMETHICONE (200 CST) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) SODIUM CITRATE MELANIN SYNTHETIC (TYROSINE, PEROXIDE) PROPANEDIOL HEXYL LAURATE SCHIZOPHYLLAN MICROCRYSTALLINE CELLULOSE ALUMINA BUTYLENE GLYCOL SODIUM CHLORIDE TIN OXIDE CI 77492 DIMETHICONE CROSSPOLYMER SILICA BISABOLOL LIMOSILACTOBACILLUS FERMENTUM POLYGLYCERYL-4 ISOSTEARATE MICA DIMETHICONE GLYCERIN TRIBEHENIN GLYCYRRHIZA URALENSIS ROOT SOYBEAN LECITHIN 1,2-HEXANEDIOL CI 77499 TRIETHOXYCAPRYLYLSILANE PENTYLENE GLYCOL CI 77491 ASCORBIC ACID STEARIC ACID ETHYLHEXYLGLYCERIN PHORMIDIUM PERSICINUM RETINYL PALMITATE ALFALFA TOP SCUTELLARIA BAICALENSIS ROOT ALPHA-TOCOPHEROL ACETATE PHENOXYETHANOL

Active ingredient
Drug Facts Active Ingredients Titanium Dioxide 5.4% Zinc Oxide 13.2%
Purpose
Propose Sunscreen
Indications and usage

Uses ■ helps prevent sunburn ■ higher SPF gives more sunburn protection ■ provides high protection against 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

Warnings and cautions
Warnings For external use only. For external use only.
Warnings
For external use only.
Do not use
on damaged or broken skin.
When using
keep out of eyes. Rinse with water to remove.
Stop use
Stop use and ask a doctor if ■ rash occurs
Ask doctor
Stop use and ask a doctor if ■ rash occurs
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage and administration

Directions ■ Apply liberally 15 minutes before sun exposure and as needed. ■ Use a water-resistant sunscreen if swimming or sweating ■ Reapply: ■ at least every 2 hours ■ Children under 6 months of age: Ask a doctor ■ 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 value 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-sleeved shirts, pants, hats, and sunglasses

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

Dimethicone, Water, Squalane, PEG-10 Dimethicone, Propanediol, Glycerin, Tribehenin, Dimethicone Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Hexyl Laurate, Polyglyceryl-4 Isostearate, Stearic Acid, Bisabolol, Lactobacillus Ferment, Cordyceps Militaris Mycelium Extract,Glycyrrhiza Uralensis (Licorice) Root Extract, Tocopheryl Acetate, Triethoxycaprylylsilane, Scutellaria Baicalensis Root Extract, Microcrystalline Cellulose, Alumina, Butylene Glycol, Sea Water (Maris Aqua/Eau de mer), Sodium Chloride, Sodium Citrate, Mica, Medicago Sativa (Alfalfa) Extract, Melanin, Pentylene Glycol, Ascorbic Acid, 1,2-Hexanediol, Phormidium Persicinum Extract, Lecithin, Phenoxyethanol, Plankton Extract, Beta-Glucan, Ethylhexylglycerin, Retinyl Palmitate, Iron Oxides (CI 77492, CI 77491, CI77499), Titanium Dioxide (CI 77891).

SPL unclassified section
Dist. by ZO Skin Health, Inc. Irvine, CA 92618 | Made in USA with US & imported materials zoskinhealth.com | 931900
Package label principal display panel
ZO® SKIN HEALTH BY ZEIN OBAGI MD NDC 42851-211-45 DAILY MINERAL SUNSHADE BROAD-SPECTRUM SUNSCREEN SPF 50 ZOX12 Light Sun Protection 45mL/ 1.5Fl.Oz. PDP
Harmonized identifiers (openFDA)
Application number
M020
Brand name
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 50 (Light)
Generic name
TITANIUM DIOXIDE, ZINC OXIDE
Manufacturer name
ZO Skin Health Inc.
Product NDC
42851-211
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
ZINC OXIDE, TITANIUM DIOXIDE
SPL ID
5ce2351f-a4f8-37f8-e063-6294a90aa116
SPL set ID
4f8756bf-5b0d-5269-e063-6294a90ae6dc
Package NDC
42851-211-45
Is original packager
true
UNII
SOI2LOH54Z, 15FIX9V2JP
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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.