FDA.reportPublic FDA data

Mackenzies SPF 40 Ocean Safe Sunscreen

Manufacturer
Naturally Uncommon LLC | Stream2Sea LLC
Effective date
2024-07-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:15:23

Label at a glance#

ProductMackenzies SPF 40 Ocean Safe Sunscreen
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

OTC - PURPOSE SECTION

Sunscreen.

INDICATIONS & USAGE SECTION

Helps prevent sunscreen.

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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.

INACTIVE INGREDIENT SECTION

Alaria Esculenta (Wakame Seaweed) Extract*, Camellia Sinensis (Green Tea) Leaf Extract*, Cera Alba (Beeswax), Cetearyl Alcohol, Cetyl Palmitate, Helianthus Annus (Sunflower) Seed Oil, Jojoba Esters, Mixed Tocopherols (Vitamin E), Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europea (Olive) Leaf Extract*, Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalene (Plant Based)

*Certified Organic Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80325-040-02Mackenzies SPF 40 Ocean Safe Sunscreen80 g in 1 JARCREAM802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80325-040MACKENZIES SPF 40 OCEAN SAFE SUNSCREEN (ZINC OXIDE) CREAM [NATURALLY UNCOMMON LLC]2Current NDC, 1 package rows20240718_1c314b70-45a7-1bd1-e063-6294a90a0d6b.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80325-04080325-040-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL PALMITATE5ZA2S6B08XIACT
ALMOND OIL66YXD4DKO9IACT
SQUALENE7QWM220FJHIACT
SUNFLOWER OIL3W1JG795YIIACT
HOLY BASIL LEAFSCJ765569PIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TOCOPHEROLR0ZB2556P8IACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
SORBITAN OLIVATEMDL271E3GRIACT
ZINC OXIDESOI2LOH54ZACTIB
ALARIA ESCULENTAEJ9JK8J58DIACT
YELLOW WAX2ZA36H0S2VIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
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
Mackenzies SPF 40 Ocean Safe SunscreenZINC OXIDENaturally Uncommon LLC1c314b70-45a7-1bd1-e063-6294a90a0d6b2024-07-17WarningsExact identifier
ndc (package): 80325-040-02
ndc (product): 80325-040
ndc11 (package): 80325004002
spl id: 1d72b0e9-1640-189d-e063-6294a90abc99
spl set id: 1c314b70-45a7-1bd1-e063-6294a90a0d6b

Reported adverse events (FAERS/openFDA)#

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