FDA.reportPublic FDA data

ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50

Manufacturer
ZO Skin Health, Inc.
Effective date
2024-11-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:34:33

Label at a glance#

ProductZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE
Label structure3 sections

Label contents#

Full prescribing information#

Drug Facts

DOSAGE & ADMINISTRATION SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsPurpose
Avobenzone 3% ...............Sunscreen
Homosalate 10%...............Sunscreen
Octisalate 5%...................Sunscreen
Octocrylene 10% ..............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.
  • 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

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, Mica, PEG-100 Stearate, Butylene Glycol, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Petasites Japonicus Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Melanin, Pentylene Glycol, Boron Nitride, Ethyl Ferulate, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate, Beta-Glucan, Ethylene Brassylate, Polymethyl
Methacrylate, Acrylates/Ammonium Methacrylate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Acrylates Crosspolymer-4, Panthenyl Triacetate, Glycerin, Aluminum Hydroxide, Simethicone, Ethyl Linoleate, Oleyl Alcohol,
Cetearyl Alcohol, PEG-8 Laurate, Steareth-2, Coco-Glucoside, Isostearic Acid, Sodium Hydroxide, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Fragrance, Titanium Dioxide, Iron Oxides.

RECENT MAJOR CHANGES SECTION

Updated Directions section’s classification from Other Safety Information to Indications & Usage.

Designated the Drug Facts parent with classification of Dosage & Administration. Preceding transmission was accepted without a category.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO® SKIN HEALTH

by ZEIN OBAGI MD

NDC 42851-055-45

Smart Tone Broad-Spectrum Sunscreen SPF 50

ZOX12 ®

ZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50ZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50

Ultra-lightweight sunscreen with customizable color beads designed to blend into most skin tones. Provides broad-spectrum protection against UVA/UVB rays. Natural melanin helps shield skin from the aging effects of high-energy visible (HEV) light. Oxybenzone free.

ZOX12 ®

Engineered with our exclusive 12-hour, time-release ZOX12 ®complex, our sunscreens help shield the skin from harmful infrared (IR-A) rays.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Made in USA with US & imported materials
zoskinhealth.com | 973380

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-055-172021-02-11C16284748780-19d75b9d0-15eb-f424-e053-dadaa90a57ceZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 National Drug Codes 42851-055-45, 42851-055-20
42851-055-452021-02-11C16284748780-19d75b9d0-15eb-f424-e053-dadaa90a57ceZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 National Drug Codes 42851-055-45, 42851-055-20
42851-055-172020-01-31C16284748780-19d75b9d0-15eb-f424-e053-dadaa90a57ceZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 National Drug Codes 42851-055-45, 42851-055-20
42851-055-452020-01-31C16284748780-19d75b9d0-15eb-f424-e053-dadaa90a57ceZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 National Drug Codes 42851-055-45, 42851-055-20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-055-20ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 5020 mL in 1 TUBELOTION206
42851-055-20ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 501 in 1 CARTONLOTION16
42851-055-45ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 5045 mL in 1 TUBELOTION456
42851-055-45ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 501 in 1 CARTONLOTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-055ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [ZO SKIN HEALTH, INC.]6Current NDC, Legacy NDC, 4 package rows20241107_cda67d41-d063-4936-a6b9-23376304eb42.zip

Products#

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

DailyMed product names page 1 of 2 · 51 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-05542851-055-45, 42851-055-20

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 49 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ETHYL FERULATE5B8915UELWIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
STEARETH-2153J3F32P58IACT
SUNFLOWER OIL3W1JG795YIIACT
PETASITES JAPONICUS ROOT6F650HF10TIACT
PENTYLENE GLYCOL50C1307PZGIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
BORON NITRIDE2U4T60A6YDIACT
DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMERT3064TZ75AIACT
MICAV8A1AW0880IACT
ROSEMARYIJ67X351P9IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
COCO GLUCOSIDEICS790225BIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ARGAN OIL4V59G5UW9XIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
OLEYL ALCOHOL172F2WN8DVIACT
ALCOHOL3K9958V90MIACT
STEARETH-2V56DFE46J5IACT
SODIUM HYDROXIDE55X04QC32IIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FERRIC OXIDE RED1K09F3G675IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOL TRIACETATE, (+)-1206E8961BIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-100 STEARATEYD01N1999RIACT

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.cda67d41-d063-4936-a6b9-23376304eb422024-11-01WarningsExact identifier
ndc (package): 42851-055-45
ndc (package): 42851-055-20
ndc (product): 42851-055
ndc11 (package): 42851005520
ndc11 (package): 42851005545
spl id: 25df0034-2b20-a2af-e063-6394a90affe7
spl set id: cda67d41-d063-4936-a6b9-23376304eb42

Reported adverse events (FAERS/openFDA)#

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