FDA.reportPublic FDA data

EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS

Product NDC
53863-005
11-digit product format
538630005
Labeler code
53863
Product ID
53863-005_2a845e4c-86e8-1799-e063-6294a90a9b2b
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octinoxate, octisalate, titanium dioxide, ensulizole
Dosage form
CREAM
Route
TOPICAL
Labeler
Exelencia importers Corp.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
TITANIUM DIOXIDE; OCTOCRYLENE; OCTISALATE; ENSULIZOLE; OCTINOXATE
Active strength
5; 10; 5; 4; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
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
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE5 g/100mL
OCTOCRYLENE10 g/100mL
OCTISALATE5 g/100mL
ENSULIZOLE4 g/100mL
OCTINOXATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
9YQ9DI1W42Internal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a845e4c-86e7-1799-e063-6294a90a9b2bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53863-005-01EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS100 mL in 1 TUBECREAM1001
53863-005-01EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53863-005EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS (OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE) CREAM [EXELENCIA IMPORTERS CORP.]1Current NDC, 2 package rows20250113_2a845e4c-86e7-1799-e063-6294a90a9b2b.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 75 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 10N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc361a514-5fc9-42a7-b1fc-28e4a11ad7332026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00 NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diordb38ced5-dfbe-4b7e-b4ae-3065df1898b02026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4ead1ce8-f31d-4676-8619-8d49dd62db2e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior827caf09-222e-487a-941c-44eb5c13d5d62026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf3c378e1-853b-463e-9fc3-6a54ef8610442026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc3a479c4-807e-4c52-a27f-eea8705b9c1e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcb63faaa-82d8-469a-a9a1-88b09e02cc352026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc20b0b8b-366a-47ff-84b6-264fa8ed6de02026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior31d89246-418d-4ed4-8e32-7aa2422073a92026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior31b74e11-c5e5-4086-baa5-e7a39dc556a02026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior29ec217b-7726-4590-8a0d-e4b08217e2222026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorceabea37-020c-49e0-a049-3100ed46ff572026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior915a0b1f-b26e-4fea-95f3-ccec2bcab3892026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior9a313d8e-003d-4d40-b892-0f2270e4f6c22026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf560de93-4099-4ad9-8eb6-fe2a52ac82a12026-01-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53863-005-01538630005011 TUBE in 1 CARTON (53863-005-01) / 100 mL in 1 TUBE1 tube2025-01-01NoNoCurrent