FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30

Product NDC
69625-113
11-digit product format
696250113
Labeler code
69625
Product ID
69625-113_c5fb25ac-e3d6-475d-981d-0ea1acdc16e8
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Cosmetique Active Production
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-15
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 50; 70 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
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE70 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
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d60887aa-7586-4d4b-88af-35b4f982aacfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69625-113-01La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 3040 mL in 1 TUBELOTION406
69625-113-01La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION16
69625-113-02La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION16
69625-113-02La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 303 mL in 1 TUBELOTION36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69625-113LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE MELA B3 UV DAILY SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [COSMETIQUE ACTIVE PRODUCTION]6Current NDC, 4 package rows20231019_d60887aa-7586-4d4b-88af-35b4f982aacf.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 176 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby RoseZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9d9419-a7e1-bc42-e063-6394a90af5112025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Shimmer Cream SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e8af968-77d5-1dcd-e063-6394a90a66992025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy ShellZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9e95c3-4ac8-5962-e063-6294a90a0c022025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 TerracottaZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9dd230-b087-cda7-e063-6394a90ae0842025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9b0642-53ed-ec94-e063-6394a90aec3d2025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d977158-8b5d-66ac-e063-6294a90a4d5c2025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Kit SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0eae4b71-60be-9715-e063-6294a90af4632025-10-20WarningsExact identifier
application number: M020
Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum SunscreenZINC OXIDEAttitude DBA 9055-7588 Qubec Inc.9ed70230-980c-474c-9f72-a6be0f3551242025-10-20WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC419b8043-7921-ca77-e063-6394a90a99ba2025-10-20WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC419c8718-6b9e-3df7-e063-6294a90a1e3b2025-10-20WarningsExact identifier
application number: M020
Sonni SunDay SerumZINC OXIDESonni419d4ada-fe9b-b774-e063-6394a90a3d092025-10-20WarningsExact identifier
application number: M020
Lip Clear Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.66f84e56-4a5d-4b71-8bd3-79961e7bf4fe2025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus Strawberry Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.2cafc97f-4cd3-4755-b394-3802c28d4ed52025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus Tangerine Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.8a00194e-9e28-4257-82e5-59bc44f7897d2025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.c9318a8c-ba3b-4068-84df-110c9005ee1d2025-10-20WarningsExact identifier
application number: M020
Terez Honor Hydro SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEWYCREAM INC418d054b-436f-6aa3-e063-6294a90a0f562025-10-19WarningsExact identifier
application number: M020
Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECosmocos Co., Ltd41129799-85ed-2de2-e063-6394a90ab40c2025-10-17WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCc5a67314-e5b2-4dd6-94e9-39c2f286c3462025-10-17WarningsExact identifier
application number: M020
LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREENZINC OXIDELion Pose Inc.0310407b-fb74-aa8b-e063-6294a90ad8412025-10-17WarningsExact identifier
application number: M020
Thrive Daily Defense Sunscreen Balm SPF30ZINC OXIDEThrive Natural Care, Inc1266bd05-1971-a7f0-e063-6394a90a089c2025-10-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69625-113-01696250113011 TUBE in 1 CARTON (69625-113-01) / 40 mL in 1 TUBE1 tube2023-10-15NoNoCurrent
69625-113-02696250113021 TUBE in 1 CARTON (69625-113-02) / 3 mL in 1 TUBE1 tube2023-10-15NoNoCurrent