Avobenzone, Homosalate, Octisalate, Octocrylene

Manufacturer
ZO Skin Health, Inc.
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:31:48

Label at a glance#

ProductZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes)
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure2 sections

Label contents#

Full prescribing information#

Drug Facts

INDICATIONS & USAGE SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active 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
■ retains SPF after 40 minutes of perspiring
■ 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

DOSAGE & ADMINISTRATION SECTION

■ Apply liberally 15 minutes before sun exposure
■ Reapply: ■ at least every 2 hours ■ after 40 minutes of swimming or sweating
■ 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

OTHER SAFETY INFORMATION

■ Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Butyloctyl Salicylate, Silica, Dimethicone, Cetearyl Alcohol, Diethylhexyl 2,6-Naphthalate, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Glyceryl Stearate, PEG-100 Stearate, Isododecane, Glycerin, Bisabolol, Propanediol, Steareth-21, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Dipotassium Glycyrrhizate, Squalane, Beta-Glucan, Melanin, Cetearyl Glucoside, Steareth-2, Polysorbate 60, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates Copolymer, Polymethyl Methacrylate, Disodium EDTA, Ethyl Ferulate, Sodium C14-16 Olefin Sulfonate, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Pentylene Glycol, 1,2-Hexanediol, Fragrance, Iron Oxides.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO® Skin Health

by Zein Obagi MD

NDC 42851-095-45

Daily Sheer Broad-Spectrum Sunscreen SPF 50

Water Resistant

(40 Minutes)

ZOX12®

45 mL / 1.5 Fl. Oz.

Daily Sheer Broad-Spectrum Sunscreen SPF 50Daily Sheer Broad-Spectrum Sunscreen SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-095-45ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes)45 mL in 1 TUBECREAM453
42851-095-45ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes)1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-095ZO SKIN HEALTH DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 50 WATER RESISTANT (40 MINUTES) (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [ZO SKIN HEALTH, INC.]3Current NDC, 2 package rows20241031_fd7d40fe-178a-e1b1-e053-6294a90a29a1.zip

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-09542851-095-45

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 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 Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.fd7d40fe-178a-e1b1-e053-6294a90a29a12024-10-29WarningsExact identifier
ndc (package): 42851-095-45
ndc (product): 42851-095
ndc11 (package): 42851009545
spl id: 259fbfe4-d67b-ea1e-e063-6294a90a0fb0
spl set id: fd7d40fe-178a-e1b1-e053-6294a90a29a1

Reported adverse events (FAERS/openFDA)#

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