FDA.reportPublic FDA data

ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50

Manufacturer
ZO Skin Health, Inc.
Effective date
2025-11-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:20:28

Label at a glance#

ProductZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50
Active ingredientOCTOCRYLENE, AVOBENZONE, OCTISALATE
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
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

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

Isododecane, Silica, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Polyamide-8, Polyester-8, Isodecyl Neopentanoate, Polyamide-3, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Diethylhexyl 2,6-Naphthalate, Diisopropyl Sebacate, Lauryl Lactate, Hydrogenated Poly(C6-20 Olefin), Bisabolol, Lupinus Albus Seed Oil, Triticum Vulgare (Wheat) Germ Extract, Glycine Soja (Soybean) Oil, Leontopodium Alpinum Meristem Cell Culture, Marrubium Vulgare Meristem Cell Culture, Tocopherol, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Melanin, Pentylene Glycol, Lecithin, Caprylyl Glycol, Glycerin, Diethylhexyl Syringylidenemalonate, HDI/Trimethylol Hexyllactone Crosspolymer, Polymethyl Methacrylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Water, Ethylhexylglycerin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO® Skin Health Gel Sunscreen Broad-Spectrum SPF 50

Water-Resistant

(40 Minutes)

ZOX12®

Secondary LabelSecondary Label

Triple-Spectrum Protection™
Protection against UVA+UVB, blue light (HEV),
and Infrared-A (IR-A) rays.
ZOX12®
Time-released antioxidant complex delivers
up to 12 hours of environmental protection.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

Made in USA with US & imported materials

zoskinhealth.com

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-092-34ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 501 in 1 CARTONGEL14
42851-092-34ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 5096 g in 1 TUBEGEL964

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-09242851-092-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ETHYLHEXYL PALMITATE2865993309IACT
ISODODECANEA8289P68Y2IACT
POLYAMIDE-8 (4500 MW)77723GV81AIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
WATER059QF0KO0RIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
TOCOPHEROLR0ZB2556P8IACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
WHEAT GERMYR3G369F5AIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
GLYCERINPDC6A3C0OXIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
POLYAMIDE-3 (12000 MW)L7P3YWF22XIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEX2PZH4Y6HTIACT
LAURYL LACTATEG5SU0BFK7OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PENTYLENE GLYCOL50C1307PZGIACT
LUPINUS ALBUS SEED OIL958BJW095QIACT
SOYBEAN OIL241ATL177AIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYDROGENATED C6-20 POLYOLEFIN (100 CST)39EYQ1W9RBIACT
LEVOMENOL24WE03BX2TIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB

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 Gel Sunscreen Broad-Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.ec8386f2-9cb7-40f4-e053-2995a90ac2d82025-11-26WarningsExact identifier
ndc (package): 42851-092-34
ndc (product): 42851-092
ndc11 (package): 42851009234
spl id: 44883680-7c35-a55f-e063-6394a90aaa42
spl set id: ec8386f2-9cb7-40f4-e053-2995a90ac2d8

Reported adverse events (FAERS/openFDA)#

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