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 74 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONSART Mineral SunscreenZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.48c9d08d-9a91-7df5-e063-6294a90a1c4a2026-01-19WarningsExact identifier
application number: M020
Intense Moisture Day CreamAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENECVS Health795d3546-f0dd-4b54-9807-9cdb3e6261812026-01-19WarningsExact identifier
application number: M020
CURESHIELD MANICURE SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD48b4fad7-073d-d983-e063-6394a90ae3142026-01-18WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65ff0448-17e6-42ce-989a-940794fcbd8c2026-01-17WarningsExact identifier
application number: M020
BenzoAzeline 10BENZOYL PEROXIDENoon Aesthetics M.R. Ltd985efa19-bd91-45cd-a2a0-d71ec325e51c2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Berry SPF 30PREQUEL LIP VISOR BERRY SPF 30The Center Brands, LLCe4f3a0eb-4a8c-4145-92e4-979f03e3a5112026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Blush SPF 30PREQUEL LIP VISOR BLUSH SPF 30The Center Brands, LLCbc681245-e158-4cfa-9718-7ec4cff0e60d2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Mahogany SPF 30PREQUEL LIP VISOR MAHOGANY SPF 30The Center Brands, LLCea8dcd14-3c54-46a6-aabc-3655f051065b2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Nude SPF 30PREQUEL LIP VISOR NUDE SPF 30The Center Brands, LLC03a7c77d-7b6e-4720-88f1-492ce57c71452026-01-16WarningsExact identifier
application number: M020
Valmont Daily Veil Moisturizing Face Fluid Mineral Sunscreen SPF 30ZINC OXIDECVL Cosmetics North America Incf3057856-1461-41d3-a5c4-9f12e3a4a0ee2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior04e9c4d8-1600-4ffc-8578-4ffb82b106f32026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1aae19da-1e73-41ed-91dc-0746ad311b872026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior22d4452d-3798-48c6-a7a4-4af0f99b4ebd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord6800bb7-16ef-48f6-a09a-0422e64ad8bd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorfb9cfd4f-a558-4df2-bbbf-b814ae19a1352026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9ddcda6-3d87-4197-a2c2-5b30016d32eb2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior25abef37-1726-491f-8a11-ac1a96378ed12026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb0e315b3-a322-4607-b212-bcadd5aa99bc2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcc0f19fc-7b6f-4454-9a77-dc11f0fd12512026-01-16WarningsExact 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