FDA.reportPublic FDA data

DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen

Product NDC
59088-568
11-digit product format
590880568
Labeler code
59088
Product ID
59088-568_23848119-f005-7528-e063-6394a90a9a0e
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, octinoxate, octisalate, titanium dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
PureTek Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-02-16
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength
25; 30; 30; 12.5 mg/mL; mg/mL; mg/mL; mg/mL
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
DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE25 mg/mL
OCTINOXATE30 mg/mL
OCTISALATE30 mg/mL
TITANIUM DIOXIDE12.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
86eb06cc-d63f-4500-a52e-14ef99a56532Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-568-05DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen56 mL in 1 BOTTLELOTION565

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-568DERMACINRX SKIN MOISTURIZING ULTRA SPF 50 SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LOTION [PURETEK CORPORATION]5Current NDC, Legacy NDC, 1 package rows20241004_86eb06cc-d63f-4500-a52e-14ef99a56532.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 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 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
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior824c5f13-970e-4e9e-8f2a-2a01973d2e592026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb7621ef5-47fc-4ccc-aedd-eac328ace7b92026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior64a29ff8-e24d-4818-9b54-734a0eb2a13f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior17a0201b-b797-4e65-838f-1ce8d408a0202026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72e2c71a-da1d-497f-a8b7-491cff951c632026-01-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-568-055908805680556 mL in 1 BOTTLE (59088-568-05) 56 ml2017-02-160000-00-00NoNoCurrent