FDA.reportPublic FDA data

ISNTREE HYALURONIC ACID DAILY SUNGEL

Product NDC
81100-501
11-digit product format
811000501
Labeler code
81100
Product ID
81100-501_4dd8cb8b-2b7a-6e0c-e063-6294a90a193e
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
ISNTREE Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-17
Substance
HOMOSALATE; AVOBENZONE; OCTISALATE
Active strength
4.5; 1.35; 2.25 g/50mL; g/50mL; g/50mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
ISNTREE HYALURONIC ACID DAILY SUNGEL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE4.5 g/50mL
AVOBENZONE1.35 g/50mL
OCTISALATE2.25 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ef5d5ce-3bdf-dffc-e063-6394a90aad54Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81100-501-01ISNTREE HYALURONIC ACID DAILY SUNGEL50 mL in 1 TUBECREAM505
81100-501-02ISNTREE HYALURONIC ACID DAILY SUNGEL1 in 1 BOXCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81100-501ISNTREE HYALURONIC ACID DAILY SUNGEL (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [ISNTREE INC.]4Current NDC, 2 package rows20240725_0ef5d5ce-3bdf-dffc-e063-6394a90aad54.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 76 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior19d1432a-96b0-4cef-b13e-895dd41b41d62026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5a06c820-ccd8-47ce-8bbf-7e90da92b1de2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior205e195a-fd30-44f7-9294-e701f0f766d62026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5495ff75-0c83-4491-8af7-4aed7a779d7f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior10bc345d-a5b1-4b70-bfa6-a2d7816904bf2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior30268b6e-d42a-4314-b82f-24f9e81cca2a2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior545c962f-2a59-4d94-8fef-ebdba4127f422026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior17c9226b-459c-42fe-ac50-7e26db6b49af2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8cb27c4e-b2f4-4e60-a5ff-7cdda79a3af62026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbf323e10-5479-44b3-b4b9-b8ca6b0f76882026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d6a5133-b847-4ecf-8c33-1cb05aca6b912026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior275be888-2c52-43ed-846a-55525002edcd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc73576a6-dbab-4205-add5-876a060b50222026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4ae761ac-df06-4913-a8bf-8ca1be32b5b72026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72c45120-6997-4250-b9b4-1cdb762efe1a2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior166e293f-3874-4fe6-8c20-2162b0d11cf12026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb048c7a5-8a71-47ea-945c-44a2d663dfa72026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore0463aa0-8e56-4dcd-8cd8-776e8a3915f22026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 10N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior038939d6-b9a5-4cb6-a818-6f7cf3f106fa2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior03c7ca69-86f1-420c-9c4c-0bf2e8553c942026-01-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81100-501-018110005010150 mL in 1 TUBE50 mlHistorical
81100-501-02811000501021 TUBE in 1 BOX (81100-501-02) / 50 mL in 1 TUBE (81100-501-01) 1 tube2024-01-17NoNoCurrent