OrgaPlus Ultra Pure Sun EX

Product NDC
69777-240
11-digit product format
697770240
Labeler code
69777
Product ID
69777-240_2d5fe924-d0d6-4e50-e063-6294a90a7ab1
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Octocrylene
Dosage form
STICK
Route
TOPICAL
Labeler
BLUEZONWIDE CO.,LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-01
Substance
OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength
1.05; .67; .3 g/15g; g/15g; g/15g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69777-240-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69777-240-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69777-240-020efc9e666f02…f202fb6c5f17…

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
OrgaPlus Ultra Pure Sun EX
Brand name suffix
15g
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE1.05 g/15g
OCTISALATE.67 g/15g
OCTOCRYLENE.3 g/15g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b686ef63-7eee-4a4d-a559-417d8b09cc4fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69777-240-022025-02-05C16284748780-12cef2736-631b-d83d-e063-dadaa90ab31fb686ef63-7eee-4a4d-a559-417d8b09cc4f
69777-240-022025-01-30C16284748780-12cef2736-631b-d83d-e063-dadaa90ab31fb686ef63-7eee-4a4d-a559-417d8b09cc4f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69777-240-01OrgaPlus Ultra Pure Sun EX15g15 g in 1 CONTAINERSTICK152
69777-240-02OrgaPlus Ultra Pure Sun EX15g1 in 1 CARTONSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69777-240ORGAPLUS ULTRA PURE SUN EX 15G (OCTINOXATE, OCTISALATE, OCTOCRYLENE) STICK [BLUEZONWIDE CO.,LTD]2Current NDC, Legacy NDC, 2 package rows20250206_b686ef63-7eee-4a4d-a559-417d8b09cc4f.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 77 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorff6a85a4-b0c5-4c2e-a698-bb315203f51b2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior262b4cfc-71c3-485e-906f-a88fe33035a82026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior30964b87-1d7c-4dd1-8ab2-bf9b8eb2ee032026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2cb4bad3-57d6-4e67-88ec-1776870c3eba2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00 NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorffd1ba9e-dd64-422a-bd69-596b5d80554d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior64943a01-5193-4c04-b623-33ceb09f10fd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diordf2e2d3f-8876-4197-bdfa-339b4f6a75712026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6cb5d7fa-4d40-46bd-9ef3-14368578cb332026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorae1e74f1-eb31-4da1-8b24-dae692d3637e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora5ce5568-708a-4af1-aa06-ea643c898bb12026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4fc4ce51-000a-42ee-952f-b4ce5f5d8a602026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorade16145-5267-4f01-bd99-f507087583f32026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4b23d8e4-b0c3-44d7-b239-a2c7ae442a2d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72471612-1ae0-493c-87c7-bf7257310e702026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior881ad126-d93f-4782-8ece-600d41a254d72026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior27bb6424-9aa6-408a-a9f4-874cb60c8f1f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorea170049-ec16-4c9d-a73d-368f6b747d572026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb6fb14f0-a3e3-4545-bb4a-f9c27190b11b2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6cb14dcf-8b70-40c3-882b-063d8922ce4c2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore4dbfd77-0eec-4d1a-94d6-4daca096d8c72026-01-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69777-240-016977702400115 g in 1 CONTAINER15 gHistorical
69777-240-02697770240021 CONTAINER in 1 CARTON (69777-240-02) / 15 g in 1 CONTAINER (69777-240-01) 1 container2018-04-010000-00-00NoNoCurrent