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 150 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Srubs SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEITW Pro Brands06c1dc42-5a01-f898-e063-6394a90a1a1a2025-12-05WarningsExact identifier
application number: M020
OUHOE Tinted SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4540f542-248d-bcf5-e063-6294a90aabca2025-12-05WarningsExact identifier
application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS45c7703b-7ab4-2ef2-e063-6294a90a2b462025-12-05WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4645b051-ef5a-521e-e063-6294a90a24042025-12-05WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen bkidsZINC OXIDEKAS Direct LLC dba BabyGanicsf717cd89-194b-42e3-a079-24b2903deb292025-12-05WarningsExact identifier
application number: M020
Sugargirl Set SPF 30 sunscreen shimmer sunscreen mist for the faceHOMOSALATE , OCTOCRYLENE ,OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b662a-70ed-8ec5-e063-6294a90a005b2025-12-04WarningsExact identifier
application number: M020
Sugargirl SPF 30 sunscreen illuminating stick sunlightHOMOSALATE ,OCTOCRYLENE ,OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b71a9-2240-853f-e063-6394a90ac8f42025-12-04WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 SCENTED gel sunscreenHOMOSALATE,OCTOCRYLENE,OCTISALATE,OCTIONXATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b7229-67d1-8b0e-e063-6394a90ab71e2025-12-04WarningsExact identifier
application number: M020
Sugargirl SPF 30 sunscreen illuminating stick solarHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b7229-67d3-8b0e-e063-6394a90ab71e2025-12-04WarningsExact identifier
application number: M020
Poolside Sun Silk Body Cream SUNGLOW 05 FRAGRANCE Sunscreen SPF 30 body creamHOMOSALATE, OCTOCRYENE, OCTISALATE, QCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b86fa-6c1c-a708-e063-6394a90a47a92025-12-04WarningsExact identifier
application number: M020
Poolside Clear Intentions Invisible Face Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b902d-892d-15f1-e063-6294a90a30242025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Vanilla IcingHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451ba227-7973-1378-e063-6294a90ae8932025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Pink IceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451ba704-6fbd-d5a0-e063-6394a90a2fbc2025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Tropic TwistHOMOSALATE,OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bb62e-b603-7663-e063-6294a90a46db2025-12-04WarningsExact identifier
application number: M020
Prequel Lip Visor SPF 30 ROSEDUSTLIP 30 CLEARThe Center Brands, LLC33d5e1ad-ba7a-25f8-e063-6294a90aa38e2025-12-04WarningsExact identifier
application number: M020
Resting Beach Face SPF30 Anti-Pollution Sunscreen SerumBUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTYL SALICYLATE, OCTOCRYLENEEveryday Group Limted54f8aca8-fbbc-498a-aaf8-aee716511dde2025-12-04WarningsExact identifier
application number: M020
Oh My Bod SPF50 Antioxidant Infused Dry Touch SunscreenBUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEEveryday Group Limted48e70326-ecf7-44c9-a4cc-2044bd6a64152025-12-04WarningsExact identifier
application number: M020
LIGHTSAVE TRIPLESOME SERUM TINTEDZINC OXIDEReve Skincare LLC35f5652f-3e6b-71c9-e063-6294a90a9e862025-12-04WarningsExact identifier
application number: M020
LIGHTSAVE TRIPLESOME SERUM IVORTYZINC OXIDEReve Skincare LLC35f4dd1b-c3d9-8408-e063-6394a90a79142025-12-04WarningsExact identifier
application number: M020
Activated Mineral Sunscreen TintedACTIVATED MINERAL SUNSCREEN TINTEDReve Skincare LLC312a32a7-d253-f10c-e063-6294a90a803a2025-12-04WarningsExact 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