FDA.reportPublic FDA data

OCEAN SAFE SUNSCREEN

Manufacturer
Naturally Uncommon, LLC | Stream2Sea, LLC
Effective date
2022-06-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:02

Label at a glance#

ProductOCEAN SAFE SUNSCREEN
Active ingredientTITANIUM DIOXIDE
Label structure8 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

8.8% Titanium Dioxide

Purpose

OTC - PURPOSE SECTION

(Non-Nano)...........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.

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

Deionized Water, Aqueous Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tenuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, Olea Europa (Olive) Leaf*, Caprylic/Capric Triglyceride, Aloe Barbadensis (Aloe) Leaf Juice*, Cocoglycerides, Glycerin, Cetearyl Alcohol, Cetyl Palmitate, Polyhydroxystearic Acid, Sorbitan Olivate, Cetearyl Olivate, Methylcellulose, Cocos Nucifera (Coconut) Oil*, Stearic Acid, Acrylates Copolymer, Magnesium Aluminum Silicate, Sorbitan Palmitate, Tocopherol, Xanthan Gum, Alumina, Benzyl Alcohol, Salicylic Acid and Sorbic Acid.
*Organic Ingredients.

MANUFACTURED FOR
NATURALLY UNCOMMON, LLC
ATKINSON, NH03811

fishermanhandscrub.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OCEAN SAFE SUNSCREEN-88 ML - NDC-80325-003-01- TUBE LABEL.

image descriptionimage description

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80325-003-012025-01-30C16284748780-12cef2736-9060-d83d-e063-dadaa90ab31fOCEAN SAFE SUNSCREEN Broad Spectrum UVA/UVB Water-Resistant 80 Minutes SAFE FOR FACE & BODY SENSITIVE SKIN FORMULA SWEAT RESISTANT FRAGRANCE FREE HIGH PERFORMANCE MINERAL BASED SUNSCREEN 3 FL OZ/ 88 ML

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80325-003-01OCEAN SAFE SUNSCREEN88 mL in 1 TUBECREAM882

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80325-003OCEAN SAFE SUNSCREEN (TITANIUM DIOXIDE) CREAM [NATURALLY UNCOMMON, LLC]2Legacy NDC, 1 package rows20220702_3a5a1871-0a1a-4387-b2af-1a3338101e5b.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
80325-00380325-003-01

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
e2192ce7-1fdb-80d1-e053-2a95a90a6ef83a5a1871-0a1a-4387-b2af-1a3338101e5b2022-06-23WarningsExact identifier
spl id: e2192ce7-1fdb-80d1-e053-2a95a90a6ef8
spl set id: 3a5a1871-0a1a-4387-b2af-1a3338101e5b

Reported adverse events (FAERS/openFDA)#

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