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 50 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sky and Sol Face and Body Sunscreen SPF 50NON- NANO ZINC OXIDEDelta Ecommerce LLC473a6ade-1f0a-c711-e063-6294a90a2b832026-03-30WarningsExact identifier
application number: M020
Vacation by Vacation Scent and Shimmer DuoAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.0c4e6fa1-c78d-4f9d-969f-135d4ed67daf2026-03-30WarningsExact identifier
application number: M020
Marie originals - ProActive SunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4e3204bf-eda4-2bdf-e063-6394a90ae4292026-03-29WarningsExact identifier
application number: M020
Sport UltraAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER37c5dcf7-dc2d-624f-e063-6394a90ae9922026-03-29WarningsExact identifier
application number: M020
ULTRALIGHT AGE DEFENSE SPF 50ZINC OXIDEGuangzhou Origin Beauty Cosmetics Co., Ltd.4e36a743-7906-2b7b-e063-6294a90af3142026-03-29WarningsExact identifier
application number: M020
Stay Put Sunscreen SPF 30OCTINOXATE 7.50% OCTISALATE 5.00% OXYBENZONE 4.00% HOMOSALATE 10.00%Sawyer Products Inc7ecba495-a912-4697-8287-2e5836e610e12026-03-27WarningsExact identifier
application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADETITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC4e0bd355-99c6-8cf4-e063-6294a90ab4b32026-03-27WarningsExact identifier
application number: M020
Vacation X AZ Lemon Tea Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.61c48acc-f589-40d3-b289-b777db5551db2026-03-27WarningsExact identifier
application number: M020
Truly Solar Baby Suncreen SPF 45HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% AVOBENZONE 3%Truly Beauty, Inc38e6c6fc-d8b9-4196-96c7-0f6d5d06da022026-03-26WarningsExact identifier
application number: M020
burndHOMOSALATE, OCTINOXATE, ZINC OXIDEBURND LLC31cf923e-fdde-790b-e063-6294a90a60ee2026-03-26WarningsExact identifier
application number: M020
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On MineralZINC OXIDE, TITANIUM DIOXIDEClassic Cosmetics LLC4df3b8c0-71bc-acdd-e063-6394a90a35c02026-03-26WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.4df77564-9da0-7e48-e063-6294a90a5e6b2026-03-26WarningsExact identifier
application number: M020
Mentholatum Natural Ice Protect Plus SPF 30 Protect Plus SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company3804a14b-be7c-a973-e063-6294a90ac7fc2026-03-25WarningsExact identifier
application number: M020
Softlips Oasis Pineapple CoconutDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companyc504463a-28bf-4161-875f-ef73520931c52026-03-25WarningsExact identifier
application number: M020
Mentholatum Natural Ice Cherry, SPF 15 CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37f2c3a6-7790-c8ec-e063-6294a90ace222026-03-25WarningsExact identifier
application number: M020
Mentholatum Natural Ice - Original, SPF 15 OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37dc44aa-17b2-8721-e063-6294a90a34f62026-03-25WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.0ef5d5ce-3bdf-dffc-e063-6394a90aad542026-03-25WarningsExact identifier
application number: M020
Silkscreen Sheer Tint Mineral Light-MediumTITANIUM DIOXIDE, ZINC OXIDECurology4ddbe349-6880-a5fc-e063-6294a90a275c2026-03-25WarningsExact identifier
application number: M020
AXIS-Y Complete No-Stress Physical Sunscreen V.3ZINC OXIDEAsia Master Trade Co.,Ltd1f310fb1-185a-b467-e063-6294a90a72fe2026-03-25WarningsExact identifier
application number: M020
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4e0450ca-147a-91d7-e063-6394a90ae73b2026-03-25WarningsExact 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