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 115 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0400b-8ad9-654b-e063-6294a90ad0402025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c00301-ee41-333c-e063-6294a90a61d52025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c078fa-05f9-ad80-e063-6394a90af3bb2025-12-16Exact identifier
application number: M020
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c108f6-a928-0a54-e063-6394a90ae6862025-12-16Exact identifier
application number: M020
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0ccca-c993-181e-e063-6294a90a7ae62025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0a55d-16d3-086a-e063-6394a90a30cf2025-12-16Exact identifier
application number: M020
Eucerin Radiant ToneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc2611e0cb-d56d-6ea1-e063-6294a90a745b2025-12-16WarningsExact identifier
application number: M020
Really Great Lip ShieldTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c1341d-fbf5-56a5-e063-6294a90aa0452025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEKLOE SALON LLC36c23c07-2011-3ddb-e063-6294a90a76e92025-12-16Exact identifier
application number: M020
Tinted Mineral Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c465ea-979b-9474-e063-6394a90ab3f82025-12-16Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c4a27b-96e9-4f30-e063-6294a90a56552025-12-16Exact identifier
application number: M020
Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDESAN JOSE MEDICAL SPA37ef19e5-1775-a8d5-e063-6394a90acaef2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEBABYFACE LLC36d69eb5-59b4-14a0-e063-6394a90a0a492025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d6141c-6967-d779-e063-6294a90af0a72025-12-16Exact identifier
application number: M020
Replenishing Daily SunscreenZINC OXIDEBABYFACE LLC36d773d7-349d-68c1-e063-6394a90aff1e2025-12-16Exact identifier
application number: M020
TiZO Tinted Moisturizing Serum - LightZINC OXIDEFallien Cosmeceuticals, Ltd.2d44158a-44b3-5a3d-e063-6294a90a1f162025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - Light-MediumZINC OXIDEFallien Cosmeceuticals, Ltd.2d53071f-0275-d00c-e063-6294a90afcca2025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - MediumZINC OXIDEFallien Cosmeceuticals, Ltd.2d550967-25af-3e7a-e063-6394a90a2c792025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - Medium-DeepZINC OXIDEFallien Cosmeceuticals, Ltd.2d57790c-22cf-08aa-e063-6394a90aeac02025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - DeepZINC OXIDEFallien Cosmeceuticals, Ltd.2d5813e8-a219-db90-e063-6294a90a6ca72025-12-16WarningsExact 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