FDA.reportPublic FDA data

MACKENZIES OCEAN SAFE SUNSCREEN

Manufacturer
Naturally Uncommon, LLC | Stream2Sea LLC | Stream2Sea, LLC
Effective date
2024-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:19

Label at a glance#

ProductMACKENZIES OCEAN SAFE SUNSCREEN
Active ingredientTITANIUM DIOXIDE
Label structure9 sections

Indications and uses

■ Helps prevent sunburn.

Dosage and administration

■ Apply liberally 15 minutes before sun exposure. ■ Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours. ■ For children under 6 months of age; ask a doctor.

Label contents#

Full prescribing information#

DRUG FACTS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (non-nano) 8.8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

■ Helps prevent sunburn.

Warnings

WARNINGS SECTION

■ For external use only.
■ Do not use on damaged or broken skin.
■ Stop use and ask a doctor if rash occurs.
■ When using this product, keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

■ Apply liberally 15 minutes before sun exposure.
■ Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
■ For children under 6 months of age; ask a doctor.

OTHER INFO

OTHER SAFETY INFORMATION

Protect this product from excessive heat and sunlight.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Alaria Esculenta (Wakame Seaweed) Extract*, Aloe Barbadensis (Aloe) Leaf Juice*, Alumina, Benzyl Alcohol, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cocoglycerides, Cocos Nucifera (Coconut Oil)*, Deionized Water, glycerin, Magnesium Aluminum Silicate, Methylcellulose, Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europea (Olive) Leaf Extract*, Polyhydroxystearic Acid, Salicylic Acid, Sorbic Acid, Sorbitan Olivate, Sorbitan Palmitate, Stearic Acid, Tocopherol, Xanthan Gum.

*Certified Organic Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80325-030-03MACKENZIES OCEAN SAFE SUNSCREEN88 mL in 1 TUBECREAM881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80325-030MACKENZIES OCEAN SAFE SUNSCREEN (TITANIUM DIOXIDE) CREAM [NATURALLY UNCOMMON, LLC]1Current NDC, 1 package rows20240817_1fd0a790-c66c-216f-e063-6294a90ae971.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80325-03080325-030-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
HOLY BASIL LEAFSCJ765569PIACT
ALARIA ESCULENTAEJ9JK8J58DIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
ALOEV5VD430YW9IACT
TRICAPRINO1PB8EU98MIACT
COCO-GLYCERIDESISE9I7DNUGIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL PALMITATE5ZA2S6B08XIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
SORBITAN OLIVATEMDL271E3GRIACT
CETEARYL OLIVATE58B69Q84JOIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
COCONUT OILQ9L0O73W7LIACT
STEARIC ACID4ELV7Z65APIACT
LUVISET 36005BG6GY6YKIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SORBITAN MONOPALMITATE77K6Z421KUIACT
TOCOPHEROLR0ZB2556P8IACT
XANTHAN GUMTTV12P4NEEIACT
ALUMINUM OXIDELMI26O6933IACT
BENZYL ALCOHOLLKG8494WBHIACT
SALICYLIC ACIDO414PZ4LPZIACT
SORBIC ACIDX045WJ989BIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
MACKENZIES OCEAN SAFE SUNSCREENTITANIUM DIOXIDENaturally Uncommon, LLC1fd0a790-c66c-216f-e063-6294a90ae9712024-08-16WarningsExact identifier
ndc (package): 80325-030-03
ndc (product): 80325-030
ndc11 (package): 80325003003
spl id: 1fd0a790-c66d-216f-e063-6294a90ae971
spl set id: 1fd0a790-c66c-216f-e063-6294a90ae971

Reported adverse events (FAERS/openFDA)#

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