FDA.reportPublic FDA data

Safe Sea SPF 50

Manufacturer
NIDARIA TECHNOLOGY LTD
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:20:39

Label at a glance#

ProductSafe Sea SPF 50
Active ingredientOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE
Label structure8 sections

Indications and 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. 

Dosage and administration

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 t...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                            Purpose

Octocrylene 10%                                Sunscreen

Homosalate 10%                                Sunscreen

Octisalate 5%                                    Sunscreen

Avobenzone 3%                                 Sunscreen

Uses

INDICATIONS & USAGE SECTION

  •  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

WARNINGS SECTION

  • For external use only
  • Do not useon damaged or broken skin 
  • When using this productkeep out of eyes. Rinse with water to remove 
  • Stop use and ask a doctorif rash occurs 

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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. 

OTHER SAFETY 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) & Rhopilema. Data on file. 
  • Protect this product from excessive heat and direct sun. 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Dibutyl Adipate, Polyglyceryl 2 Dipolyhydroxystearate, Stearyl Dimethicone, Cetyl Dimethicone, Magnesium Stearate, Hydrogenated Castor Oil, Benzyl alcohol, Lanthanum Chloride, Magnesium Chloride, Calcium Chloride, Glycosaminoglycans, Glycoproteins, Plankton Extract, Parfum(Fragrance), Chlorphenisin, Panthenol, Tocopheryl Acetate, Dehydroacetic Acid, Benzoic Acid, Sorbic Acid 

Questions or comments?

OTC - QUESTIONS SECTION

mail@nidaria.com

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65435-0800-1Safe Sea SPF 50100 mL in 1 TUBELOTION1001

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65435-080065435-0800-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIBUTYL ADIPATEF4K100DXP3IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
MAGNESIUM STEARATE70097M6I30IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
BENZYL ALCOHOLLKG8494WBHIACT
LANTHANUM CHLORIDE04M8624OXVIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
CHLORPHENESINI670DAL4SZIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DEHYDROACETIC ACID2KAG279R6RIACT
BENZOIC ACID8SKN0B0MIMIACT
SORBIC ACIDX045WJ989BIACT
PHAEODACTYLUM TRICORNUTUMY5W63E7HLVIACT
SACCHAROMYCES CEREVISIAE978D8U419HIACT
POLYSULFATED GLYCOSAMINOGLYCAN268AW7000TIACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

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
Safe Sea SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD46641a33-d658-4ef0-9b7a-062adc401dde2025-12-08WarningsExact identifier
ndc (package): 65435-0800-1
ndc (product): 65435-0800
ndc11 (package): 65435080001
spl id: 457011d6-f0af-9c08-e063-6394a90aa975
spl set id: 46641a33-d658-4ef0-9b7a-062adc401dde

Reported adverse events (FAERS/openFDA)#

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