FDA.reportPublic FDA data

DR ANDREW WEILS FOR ORIGINS

Product NDC
59427-113
11-digit product format
594270113
Labeler code
59427
Product ID
59427-113_051acbc2-7bef-4059-e063-6394a90a115b
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
ORIGINS NATURAL RESOURCES INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
63; 40 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
DR ANDREW WEILS FOR ORIGINS
Brand name suffix
MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE63 mg/mL
ZINC OXIDE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
11248cab-c3a5-4e16-8280-9f70bb863cf7Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-08-12DR WEILS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45 SUNCREEN
2022-07-29DR WEILS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45 SUNCREEN
2021-08-19DR WEILS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45 SUNCREEN
2021-07-23DR WEILS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45 SUNCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59427-113-01DR ANDREW WEILS FOR ORIGINSMEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 451 in 1 CARTONLOTION17
59427-113-01DR ANDREW WEILS FOR ORIGINSMEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 4530 mL in 1 BOTTLELOTION307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59427-113DR ANDREW WEILS FOR ORIGINS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [ORIGINS NATURAL RESOURCES INC.]7Current NDC, Legacy NDC, 2 package rows20231020_11248cab-c3a5-4e16-8280-9f70bb863cf7.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 126 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Titanium Dioxide, Zinc OxideON THE GO SUNSCREEN STICKREVIVE IN SOLANO36c57e6f-c747-9926-e063-6294a90a57212025-12-15Exact identifier
application number: M020
Daily Shade Dewy Glow TintedZINC OXIDEBLISS BEAUTY LLC373babab-2949-5474-e063-6394a90aacd72025-12-15Exact identifier
application number: M020
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC3739bdb8-2152-b2ba-e063-6294a90acd942025-12-15Exact identifier
application number: M020
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC37396a51-225d-7669-e063-6294a90af6d32025-12-15Exact identifier
application number: M020
Daily Shade Dewy Glow TintedZINC OXIDEBLISS BEAUTY LLC373a4c37-e280-bacb-e063-6394a90a5af82025-12-15Exact identifier
application number: M020
Daily Shade Sheer MatteZINC OXIDEBLISS BEAUTY LLC373a0d67-b225-ecb0-e063-6294a90a9ac12025-12-15Exact identifier
application number: M020
Daily Shade Sheer MatteZINC OXIDEBLISS BEAUTY LLC373b3e56-f923-dd24-e063-6294a90acf532025-12-15Exact identifier
application number: M020
Tinted Lip Shade SunscreenTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC373a7c01-ba9f-4b00-e063-6294a90ae1a22025-12-15Exact identifier
application number: M020
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC373b7ab9-c692-fc1b-e063-6294a90aa8032025-12-15Exact identifier
application number: M020
Antioxidant Mineral Sunscreen Plus Primer Lightly TintedZINC OXIDETrue Beauty Brows & Skin Care37dc4599-bd97-8c85-e063-6294a90ad1dc2025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36af24e2-015a-a9a7-e063-6294a90a2fce2025-12-15Exact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36add3a3-f1ff-3986-e063-6394a90ab7fe2025-12-15Exact identifier
application number: M020
Antioxidant Mineral Sunscreen Plus Primer Lightly TintedZINC OXIDETrue Beauty Brows & Skin Care37dc70ba-a6bb-fe09-e063-6394a90a51292025-12-15Exact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCbcbab676-fbe2-f0cc-e053-2a95a90ad4d22025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf14cf2b8-b110-1210-e053-2995a90a01022025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf1504311-4865-5499-e053-2995a90acdcd2025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf14d70f1-440b-900d-e053-2995a90a30a02025-12-15WarningsExact identifier
application number: M020
REVERSE Brightening Defense FluidAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATERodan & Fieldsdc230e1e-bfb8-4d7c-bad5-bff77d78220e2025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC MINERAL SPORT SPF50TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCbbf15e58-c160-d599-e053-2a95a90a06962025-12-14WarningsExact identifier
application number: M020
Mineral Sunscreen Stick SPF 50 Fragrance-FreeZINC OXIDECOOLA LLCee8706b0-ad42-403a-be7c-b660f040a2442025-12-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59427-113-01594270113011 BOTTLE in 1 CARTON (59427-113-01) / 30 mL in 1 BOTTLE1 bottle2016-02-150000-00-00NoNoCurrent