FDA.reportPublic FDA data

Sunblocz

Manufacturer
Olen Skin Care Corporation
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:31:45

Label at a glance#

ProductSunblocz
Active ingredientZINC OXIDE
Label structure15 sections

Storage and handling

Other information Protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc Oxide 24.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Uses

  • Helps prevent 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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply liberally and evenly 15 minutes before sun exposure
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. -2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Grape Seed Oil, Safflower Oil, Beeswax, Candelilla wax, Rice Bran Wax, Green Tea, Iron Oxide, Lavender Essential Oil, Rosemary Essential Oil.

SPL UNCLASSIFIED SECTION

Manufactured for:

Olen Cosmetics Corporation

31 Woodstone Drive

East St. Paul, Manitoba

Canada, R2EOM5

Made in Canada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunblocz

100% NATURAL

ZINC OXIDE SUNSCREEN CREAM

NATURALLY TINTED

BROAD SPECTRUM SPF 50

UVA & UVB

Water Resistant (80 minutes)

Dermatologist Recommended

Clinically Tested

Hypoallergenic

6 FL OZ (177 mL)

SunBloczSunBlocz

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52358-0004-1Sunblocz177 mL in 1 TUBECREAM1776
52358-0004-2Sunblocz118 mL in 1 TUBECREAM1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52358-0004SUNBLOCZ (ZINC OXIDE) CREAM [OLEN SKIN CARE CORPORATION]6Current NDC, Legacy NDC, 2 package rows20241031_36fec1f1-5e8b-5764-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52358-000452358-0004-1, 52358-0004-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAVENDER OILZBP1YXW0H8IACT
ROSEMARY OIL8LGU7VM393IACT
BROWN IRON OXIDE1N032N7MFOIACT
CANDELILLA WAXWL0328HX19IACT
SAFFLOWER OIL65UEH262ISIACT
YELLOW WAX2ZA36H0S2VIACT
RICE BRANR60QEP13ICIACT
ZINC OXIDESOI2LOH54ZACTIM
GRAPE SEED OIL930MLC8XGGIACT
GREEN TEA LEAFW2ZU1RY8B0IACT

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
SunbloczZINC OXIDEOlen Skin Care Corporation36fec1f1-5e8b-5764-e054-00144ff8d46c2024-10-29WarningsExact identifier
ndc (package): 52358-0004-2
ndc (package): 52358-0004-1
ndc (product): 52358-0004
ndc11 (package): 52358000401
ndc11 (package): 52358000402
spl id: 259f1fe0-327b-a04f-e063-6394a90a534d
spl set id: 36fec1f1-5e8b-5764-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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