FDA.reportPublic FDA data

Safe Sea SPF 50 kids

Product NDC
65435-0200
11-digit product format
654350200
Labeler code
65435
Product ID
65435-0200_4584a0f3-ef34-c289-e063-6294a90ad706
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 kids
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
3fa04557-2bc1-4eb4-aed8-eacc79189613Available 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
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
65435-0200-1Safe Sea SPF 50 kids118 mL in 1 BOTTLELOTION1189

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65435-0200SAFE SEA SPF 50 KIDS (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [NIDARIA TECHNOLOGY LTD]7Current NDC, Legacy NDC, 1 package rows20241123_3fa04557-2bc1-4eb4-aed8-eacc79189613.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 211 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences4c7f0257-fa12-40d6-9516-824b0e3a182c2025-06-05WarningsExact identifier
application number: M020
Mineral KidCreme SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences9ec56c68-6fea-444b-aeed-0b5d60c42e752025-06-05WarningsExact identifier
application number: M020
Kidspray Broad Spectrum Sunscreen SPF 40AVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences36df811b-35d2-261d-e063-6394a90aa91e2025-06-05WarningsExact identifier
application number: M020
5-IN-1 TINTED FACE SUNSCREEN - FAIRZINC OXIDESynchronicity Spa, Inc. DBA Suntegrityc0892856-cd12-4c1f-8420-866dbd0f89072025-06-04WarningsExact identifier
application number: M020
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCfbf8be03-93e2-4d7e-e053-6294a90a4fd52025-06-04WarningsExact identifier
application number: M020
EltaMD UV Clear SPF46ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.60438ec5-0b1f-45fd-8ce4-debfdbdc67212025-06-04WarningsExact identifier
application number: M020
LikePro Skincare Sport Day UV Face Sunscreen SPF 50OCTOCRYLENE, ZINC OXIDELIKE PRO OPTIMAL SKINCARE LLCb00d0efe-bf22-43a6-ba24-3d5b6ee9c5e12025-06-03WarningsExact identifier
application number: M020
LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50ZINC OXIDELIKE PRO OPTIMAL SKINCARE LLC2ea86aa8-2f28-40bb-9318-fec188f660102025-06-03WarningsExact identifier
application number: M020
LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50ZINC OXIDELIKE PRO OPTIMAL SKINCARE LLCb59a3b67-0e44-426d-9379-0ca31628937a2025-06-03WarningsExact identifier
application number: M020
EthoSun EthoSport Stick Broad Spectrum SPF 40ZINC OXIDEEthoSun, Inc35372859-8f40-5eb0-e063-6294a90a6a002025-06-03WarningsExact identifier
application number: M020
EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45ZINC OXIDEEthoSun, Incd7d2bca6-5000-4cb9-b004-b1ae286f60352025-06-03WarningsExact identifier
application number: M020
Age Defense for Eyes 5 in 1ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.48d5343a-1068-4c64-a275-c180026d69472025-06-03WarningsExact identifier
application number: M020
Ola Botanicals Sunscreen SPF 30ZINC OXIDENatural Health Partners, LLCc7a7df0b-da8f-407d-a1ee-28f75070b23c2025-06-02WarningsExact identifier
application number: M020
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDEExpanscience Laboratories d/b/a Mustela95ea5442-a7ca-0c7d-e053-2a95a90ad2472025-06-02WarningsExact identifier
application number: M020
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
application number: M020
Sunny Sailor First Mate Face Stick SPF 30ZINC OXIDESUNNY SAILOR LLC8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e2025-05-28WarningsExact identifier
application number: M020
Dr Mercola Broad Spectrum SPF15ZINC OXIDENatural Health Partners, LLC47f6b19e-ede8-0daf-e054-00144ff88e882025-05-28WarningsExact identifier
application number: M020
Dr. Mercola Broad SpectrumZINC OXIDENatural Health Partners, LLC47f6ec0a-1144-55dd-e054-00144ff8d46c2025-05-28WarningsExact identifier
application number: M020
Dr. Mercola Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDENatural Health Partners, LLC47f6ab9e-fa73-496a-e054-00144ff8d46c2025-05-28WarningsExact identifier
application number: M020
Celavive Protective Day SPF 30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENEUSANA Health Sciences, Inc.cf00763f-6b3e-4d50-b639-9a6d6f5959612025-05-28WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65435-0200-165435020001118 mL in 1 BOTTLE (65435-0200-1) 118 ml2021-04-300000-00-00NoNoCurrent
65435-0200-265435020002100 mL in 1 TUBE (65435-0200-2) 100 ml2021-11-050000-00-00NoNoCurrent