Safe Sea SPF 60

Manufacturer
SASA Cosmetics
Effective date
2016-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:25

Label at a glance#

ProductSafe Sea SPF 60
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  Aqua, Cyclopentasiloxane, Stearyl Dimethicone, Cetyl Dimethicone,

Propylene Glycol, Lauryl PEG / PPG - 18/18 Methicone, Cetyl PEG/PPG-10/1 Dimethicone,

Hydrogenated Castor Oil,  Panthenol, Tocopheryl Acetate, Lanthanum Chloride,

Magnesium Chloride, Calcium Chloride, Plankton Extract, Glycoproteins, Glycosaminoglycans,

Benzyl Alcohol, Fragrance, Chlorphenesin, Benzoic Acid, Sorbic Acid, Dehydroacetic Acid,

Tetrasodium EDTA, Sodium Citrate, Triethoxycaprylylsilane, Trimethoxycaprylylsilane

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Octinoxate 7.5 %

Octisalate 5 %

Zinc Oxide 5 %

Titanium Dioxide 2 %

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

Warning: -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 sue and ask a doctor if rash occurs--Keep out of reach

of children -- If product is swallowed, get medical help or contact a Poison

Control Center right away.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Apply liberally 15 minutes before sun exposure --

reapply. After 80 minutes of swimming or sweating, immediately after towel

drying and 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 of

15 or higher and other sun protection measures including: - Limit time

in the sun, especially from 10 a.m. to 2 p.m.  -- Wear long-sleeve shirts, pants,

hats, and sunglasses -- Children under 6 months: Ask a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or

contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

Other Information: Give particular attention to coverage of arms

and legs. - In water infested by Sea Lice, Safe Sea should also be applied under the

bathing suit. - Jellyfish can be dangerous. This product should not be considered  a

recommendation to go into jellyfish infested water, nor is it

a guarantee against stings. - In case of sting do not use Safe Sea

as a treatment - seek medical attention.

Tested against Sea nettle ( Chrysaora ) Atlantic Box jellyfish (Chiropsalmus )

and Rhopilema. Data on file.  - Protect this product form excessive heat

and direct sunlight

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66134-060-602020-01-31C16284748780-19d75b9d0-e20f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66134-060-60Safe Sea SPF 60118 g in 1 TUBELOTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66134-060SAFE SEA SPF 60 (OCTINOXATE, OCTISALATE, AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]1Legacy NDC, 1 package rows20160316_cb6f18fe-35ef-4145-908f-0e9b6cd27754.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66134-06066134-060-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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
4df72aa6-36a4-4e30-87ed-b6f1c3c787dbcb6f18fe-35ef-4145-908f-0e9b6cd277542016-03-15WarningsExact identifier
spl id: 4df72aa6-36a4-4e30-87ed-b6f1c3c787db
spl set id: cb6f18fe-35ef-4145-908f-0e9b6cd27754

Reported adverse events (FAERS/openFDA)#

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