FDA.reportPublic FDA data

SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV

Product NDC
85796-2805
11-digit product format
857962805
Labeler code
85796
Product ID
85796-2805_5a501672-9396-1ec8-e063-6394a90a5485
Type
HUMAN OTC DRUG
Nonproprietary name
Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate, Homosalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
Craver Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
Substance
OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE
Active strength
9; 4.5; 13.6; 2.7 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE9 g/100mL
OCTISALATE4.5 g/100mL
HOMOSALATE13.6 g/100mL
AVOBENZONE2.7 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
38d8c1c9-86b5-1edd-e063-6394a90aeb47Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85796-2805-1SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV1 in 1 BOXCREAM13
85796-2805-1SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV50 mL in 1 CONTAINERCREAM503
85796-2805-2SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV2 in 1 BOXCREAM23
85796-2805-2SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV50 mL in 1 CONTAINERCREAM503

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 61 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENSaltair Body LLC4b9ac780-ef7d-42fc-e063-6394a90ad62f2026-02-24WarningsExact identifier
application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENSaltair Body LLC4b9b36a6-4da9-8439-e063-6394a90aa86b2026-02-24WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
application number: M020
cle de peau BEAUTE ADVANCED PROTECTIVE DAYAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation710975d8-43bf-40b9-82c2-d4dc2988956d2026-02-23WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
application number: M020
Eryfotona AgelessZINC OXIDEISDIN Corp.a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f2026-02-23WarningsExact identifier
application number: M020
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
application number: M020
Beauty HydratingHOMOSALATE, ZINC OXIDEMeijer, Inc.69b72139-757f-476d-99d2-33f5524c41d22026-02-19Warnings, Adverse reactionsExact identifier
application number: M020
daily moisturizerAVBENZONE, OCTISALATE, OCTOCRYLENEMeijer, Inc.6d301146-46e0-445c-b14e-3ec8ce76cb452026-02-19Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer, Inc.e9f4a2bb-d21e-4b38-9a37-23c23c8ad8572026-02-19Warnings, Adverse reactionsExact identifier
application number: M020
Inkeeze Tattoo Products Hi-Definition Tattoo Sunscreen SPF 50 Coconut ScentAVOBENZONE, OCTISALATE, OCTOCRYLENEInk-eeze3f759bec-4e33-46fa-a800-fa3a17d63df92026-02-19WarningsExact identifier
application number: M020
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
application number: M020
e.l.f. Best and Obsessed Skincare SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.4b1c1150-5ac5-4a8b-e063-6394a90a54102026-02-18WarningsExact identifier
application number: M020
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
application number: M020
Degree ClinicalCOOL RUSH INVISIBLE SOLID 96H ANTIPERSPIRANT DEODORANTConopco Inc. d/b/a/ Unilever4b1f9fd3-3c49-9a98-e063-6294a90a20e02026-02-18WarningsExact identifier
application number: M020
e.l.f. Wake the E.L.F. Up Skincare SetAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATEe.l.f. Cosmetics, Inc4b20c56a-3e91-3419-e063-6294a90ad3612026-02-18WarningsExact identifier
application number: M020
Dermatone Mineral SPF 30ZINC OXIDE 20%Dermatone Labs LLC26e3209f-cb5c-484e-9b2e-74dc397d47902026-02-18WarningsExact identifier
application number: M020
SHISEIDO ESSENTIAL ENERGY HYDRATING DAYHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION8b88039a-09fe-458b-b80f-49cde49b65952026-02-17WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED nAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf3729d0b-e601-48bb-9907-1d6e3ab319962026-02-17WarningsExact identifier
application number: M020
Luminesce Daily Moisturizing ComplexAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEVelovita Inc.4b0c2213-8667-be6f-e063-6394a90a5e862026-02-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85796-2805-1857962805011 CONTAINER in 1 BOX (85796-2805-1) / 50 mL in 1 CONTAINER1 container2025-09-01NoNoCurrent
85796-2805-2857962805022 CONTAINER in 1 BOX (85796-2805-2) / 50 mL in 1 CONTAINER2 container2025-09-01NoNoCurrent