FDA.reportPublic FDA data

Safe Sea SPF 50

Product NDC
65435-0100
11-digit product format
654350100
Labeler code
65435
Product ID
65435-0100_45849749-2d41-84a5-e063-6394a90acdbe
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octocrylene, Octisalate, Avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
NIDARIA TECHNOLOGY LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-30
Substance
OCTOCRYLENE; HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength
100; 100; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Safe Sea SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE100 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
AVOBENZONE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
53df3126-1136-490a-b339-5876ce89499eAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65435-0100-1Safe Sea SPF 50118 mL in 1 BOTTLELOTION1189

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65435-0100SAFE SEA SPF 50 (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [NIDARIA TECHNOLOGY LTD]7Current NDC, Legacy NDC, 1 package rows20241123_53df3126-1136-490a-b339-5876ce89499e.zip

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 187 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Blueberry Nutri Tint SPF 20 15N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L8d76a963-bdf5-44a1-b1d6-27d1a3aaa1ae2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 16N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.Ld279693f-2254-4f3c-a121-144f95f9f25d2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 12N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L7f007540-8271-4d85-9d1e-b2b273ca05f82025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 17W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L5198d3df-ffa8-45eb-93d1-11e9f3961b922025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 18N MediumZINC OXIDEDolce & Gabbana Beauty S.R.La82d85c4-c6ef-4083-b67a-2d6b0e8fc10d2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 19W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L4ee6cac6-f649-436c-ada2-e024b86add692025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 24N MediumZINC OXIDEDolce & Gabbana Beauty S.R.Ledd4e8c3-b47a-4cfe-bf20-e856edb76e212025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 21W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L457f0a5c-c543-44f8-82d6-1096a8aab9842025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 22N MediumZINC OXIDEDolce & Gabbana Beauty S.R.L1452ffc4-a83f-472f-ae70-9e1002f889452025-09-08WarningsExact identifier
application number: M020
Ocean Potion Suncare 50 Continuous Sunscreen Scent of SunshineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3e518d8a-f52b-4ae1-e063-6394a90aaa1e2025-09-08WarningsExact identifier
application number: M020
Ocean Potion Suncare 50 Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3c5a624a-8844-b782-e063-6294a90a478c2025-09-08WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dbb07e2-971c-284d-e063-6294a90a437f2025-09-06WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3e069cb2-c4c5-abf5-e063-6394a90a56b02025-09-06WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 2C LightZINC OXIDEDolce & Gabbana Beauty S.R.L761ce50c-2bf5-4ed0-91ac-9c47f8790ddb2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 3W LightZINC OXIDEDolce & Gabbana Beauty S.R.L2781b921-eb0d-4270-addf-47301577b28c2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 5N LightZINC OXIDEDolce & Gabbana Beauty S.R.L893434a1-72b8-4f0f-bfaa-2c9d775d7e272025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 7N LightZINC OXIDEDolce & Gabbana Beauty S.R.L199d97a2-d32b-45ab-a43d-30522b0ca5962025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 10N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L638eafb5-08a8-425f-893f-d6609b868e2b2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 9C Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L41fd80a9-2c6f-4f3e-a37d-e781965ddc552025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 11W Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L50bac9fb-5b81-4cdd-9eae-ec9530fc46c32025-09-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65435-0100-165435010001118 mL in 1 BOTTLE (65435-0100-1) 118 ml2021-04-300000-00-00NoNoCurrent
65435-0100-265435010002100 mL in 1 TUBE (65435-0100-2) 100 ml2021-11-050000-00-00NoNoCurrent