ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50

Manufacturer
ZO Skin Health, Inc.
Effective date
2024-11-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:33:34

Label at a glance#

ProductZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50
Active ingredientOCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE
Label structure2 sections

Label contents#

Full prescribing information#

Drug Facts

DOSAGE & ADMINISTRATION SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

IngredientsPurpose
Avobenzone 3.0%.............Sunscreen
Homosalate 6.8%.............Sunscreen
Octisalate 5.0%................ Sunscreen
Octocrylene 10.0%................ Sunscreen

Uses

OTC - PURPOSE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.
When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.
Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INDICATIONS & USAGE SECTION

  • 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 Information

STORAGE AND HANDLING SECTION

  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Mica, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Petasites Japonicus Root Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Propylene Glycol Stearate, Melanin, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Beta-Glucan, Glycerin, Ethyl Linoleate, Oleyl Alcohol, Acrylates Crosspolymer-4, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Stearate, Panthenyl Triacetate, Cetearyl Alcohol, PEG-8 Laurate, Coco-Glucoside, Steareth-2, Polymethyl Methacrylate, Cellulose Acetate,Acrylates/Ammonium Methacrylate Copolymer, Simethicone, Disodium EDTA, Sodium Hydroxide, Ethyl Ferulate, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Ethylene Brassylate, Fragrance, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77492, 77499).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

US Smart Tone 45 mL Unit CartonUS Smart Tone 45 mL Unit Carton

ZO® SKIN HEALTH

by ZEIN OBAGI MD

NDC 42851-096-45

Smart Tone Broad-Spectrum Sunscreen SPF 50

ZOX12 ®

45 mL / 1.5 Fl. Oz.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-096-20ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 501 in 1 CARTONLOTION12
42851-096-20ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 5045 mL in 1 TUBELOTION452
42851-096-45ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 501 in 1 CARTONLOTION12
42851-096-45ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 5045 mL in 1 TUBELOTION452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-096ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [ZO SKIN HEALTH, INC.]2Current NDC, 4 package rows20241105_1560a6b6-8d4a-6942-e063-6294a90a4a44.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 52 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-09642851-096-20, 42851-096-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 50 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.1560a6b6-8d4a-6942-e063-6294a90a4a442024-11-04WarningsExact identifier
ndc (package): 42851-096-20
ndc (package): 42851-096-45
ndc (product): 42851-096
ndc11 (package): 42851009620
ndc11 (package): 42851009645
spl id: 261d72c0-ea75-2024-e063-6394a90a65b9
spl set id: 1560a6b6-8d4a-6942-e063-6294a90a4a44

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.