FDA.reportPublic FDA data

Stream2Sea Broad Spectrum 30 - Tinted

Product NDC
69555-031
11-digit product format
695550031
Labeler code
69555
Product ID
69555-031_42f52562-2470-9e85-e063-6294a90af104
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Stream2Sea, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-13
Substance
TITANIUM DIOXIDE
Active strength
1 g/88mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stream2Sea Broad Spectrum 30 - Tinted
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE1 g/88mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69555-031-302025-11-25C16284748780-1ba0f9c33-3057-a910-e053-dadaa90a0b85Stream2Sea Sport Broad Spectrum
69555-031-322025-11-25C16284748780-1ba0f9c33-3057-a910-e053-dadaa90a0b85Stream2Sea Sport Broad Spectrum
69555-031-902025-11-25C16284748780-1ba0f9c33-3057-a910-e053-dadaa90a0b85Stream2Sea Sport Broad Spectrum
69555-031-912025-11-25C16284748780-1ba0f9c33-3057-a910-e053-dadaa90a0b85Stream2Sea Sport Broad Spectrum
69555-031-302025-01-30C16284748780-1ba0f9c33-3057-a910-e053-dadaa90a0b85Stream2Sea Sport Broad Spectrum
69555-031-322025-01-30C16284748780-1ba0f9c33-3057-a910-e053-dadaa90a0b85Stream2Sea Sport Broad Spectrum
69555-031-902025-01-30C16284748780-1ba0f9c33-3057-a910-e053-dadaa90a0b85Stream2Sea Sport Broad Spectrum
69555-031-912025-01-30C16284748780-1ba0f9c33-3057-a910-e053-dadaa90a0b85Stream2Sea Sport Broad Spectrum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69555-031-30Stream2Sea Broad Spectrum 30 - Tinted30 mL in 1 TUBELOTION3010
69555-031-32Stream2Sea Broad Spectrum 30 - Tinted946 mL in 1 TUBELOTION94610
69555-031-90Stream2Sea Broad Spectrum 30 - Tinted90 mL in 1 TUBELOTION9010
69555-031-91Stream2Sea Broad Spectrum 30 - Tinted75 mL in 1 TUBELOTION7510

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1
CETEARYL OLIVATEINACTIVE INGREDIENT58B69Q84JOSTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1
CETEARYL PALMITATEINACTIVE INGREDIENTUVI52NPK6GSTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XSTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZSTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1
SORBITAN MONOPALMITATEINACTIVE INGREDIENT77K6Z421KUSTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESTREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION [STREAM2SEA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69555-031STREAM2SEA BROAD SPECTRUM 30 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 30 - TINTED (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 (TITANIUM DIOXIDE) LOTION STREAM2SEA BROAD SPECTRUM 20 - TINTED (TITANIUM DIOXIDE) LOTION [STREAM2SEA, LLC]9Current NDC, Legacy NDC, 4 package rows20231212_1775d07d-6914-6928-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69555-031-306955500313030 mL in 1 TUBE (69555-031-30) 30 ml2021-02-130000-00-00NoNoCurrent
69555-031-3269555003132946 mL in 1 TUBE (69555-031-32) 946 ml2021-02-130000-00-00NoNoCurrent
69555-031-906955500319090 mL in 1 TUBE (69555-031-90) 90 ml2021-02-130000-00-00NoNoCurrent
69555-031-916955500319175 mL in 1 TUBE (69555-031-91) 75 ml2023-12-11NoNoCurrent