FDA.reportPublic FDA data

LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 Sunscreen

Product NDC
49967-043
11-digit product format
499670043
Labeler code
49967
Product ID
49967-043_6a9b680d-ea91-44fd-94fd-bee18621aca2
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate
Dosage form
LIQUID
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-26
Substance
OCTINOXATE
Active strength
32 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49967-04349967-043-01DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE32 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
82a6fbba-f0d4-475f-9ba7-615118eed70dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-043-01LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 Sunscreen30 mL in 1 BOTTLELIQUID303
49967-043-02LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 Sunscreen30 mL in 1 TUBELIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-043LOREAL PARIS INFALLIBLE PROGLOW BROAD SPECTRUM SPF 15 SUNSCREEN (OCTINOXATE) LIQUID [L'OREAL USA PRODUCTS INC]3Current NDC, Legacy NDC, 2 package rows20231230_82a6fbba-f0d4-475f-9ba7-615118eed70d.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 146 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safe Sea SPF sport 65HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD0ed3242b-ac35-4d98-a777-1e44bb32a4672025-12-08WarningsExact identifier
application number: M020
Safe Sea SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD46641a33-d658-4ef0-9b7a-062adc401dde2025-12-08WarningsExact identifier
application number: M020
Skin Filter Glow SPFZINC OXIDEMALORIE MILES36485f44-a6bd-9529-e063-6294a90af7a42025-12-08Exact identifier
application number: M020
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3647f983-9e75-8955-e063-6294a90af1622025-12-08Exact identifier
application number: M020
Body-ScreenZINC OXIDEMALORIE MILES36499be5-d680-92bf-e063-6394a90a89db2025-12-08Exact identifier
application number: M020
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3649f758-e31b-3c6a-e063-6294a90a5c362025-12-08Exact identifier
application number: M020
Body-ScreenZINC OXIDEMALORIE MILES364ae392-480a-14ea-e063-6394a90a38832025-12-08Exact identifier
application number: M020
Personalized Moisturizer SPF 30ZINC OXIDE 10.00%Proven Skincared3cf8f81-d6ae-4570-ad86-43415e973e132025-12-08WarningsExact identifier
application number: M020
GLOW SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2f9d087c-b2b3-5654-e063-6294a90a94e52025-12-08WarningsExact identifier
application number: M020
MATTE SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2faee7ef-fc0c-6d01-e063-6294a90a6d682025-12-08WarningsExact identifier
application number: M020
GLOW SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2faf530d-5574-b702-e063-6294a90ad6fd2025-12-08WarningsExact identifier
application number: M020
MATTE SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2fb00db0-4c37-56c6-e063-6294a90a8aff2025-12-08WarningsExact identifier
application number: M020
Matte Shield SPFTITANIUM DIOXIDE, ZINC OXIDEACNE SOLUTIONS NYC INC3bb582ec-71e7-4ad8-e063-6394a90a94d42025-12-08WarningsExact identifier
application number: M020
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334afdc8-1e12-d787-e063-6294a90aed7c2025-12-08Exact identifier
application number: M020
SPF 101 Non-TintedZINC OXIDEThe Acne Lab LLC334bf8ea-2485-84e8-e063-6294a90aefa62025-12-08Exact identifier
application number: M020
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334d694a-f9e4-ae86-e063-6394a90abfe12025-12-08Exact identifier
application number: M020
SPF 101 Non-TintedZINC OXIDEThe Acne Lab LLC334e32a4-c3a5-e37d-e063-6294a90ad6cf2025-12-08Exact identifier
application number: M020
Mineral Based Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245561d-a90c-7bf0-e063-6394a90ab3b62025-12-08Exact identifier
application number: M020
Mineral Based Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245c1f7-2c1b-b6ad-e063-6394a90aaee62025-12-08Exact identifier
application number: M020
Mineral Based Facial SunscreenZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3e8981ed-5847-7009-e063-6394a90a49a12025-12-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-043-014996700430130 mL in 1 BOTTLE (49967-043-01) 30 ml2016-02-260000-00-00NoNoCurrent
49967-043-024996700430230 mL in 1 TUBE (49967-043-02) 30 ml2016-02-260000-00-00NoNoCurrent