FDA.reportPublic FDA data

RoC Hydration Plus SPF 30

Product NDC
73496-014
11-digit product format
734960014
Labeler code
73496
Product ID
73496-014_45a3e259-aa75-67c1-e063-6294a90a850a
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Roc Skincare
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-27
Substance
OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE
Active strength
4.5; 5.5; 2; 4 mg/100mL; mg/100mL; mg/100mL; mg/100mL
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
RoC Hydration Plus SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE4.5 mg/100mL
HOMOSALATE5.5 mg/100mL
AVOBENZONE2 mg/100mL
OCTOCRYLENE4 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal 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
45a3e250-8195-344d-e063-6294a90ae681Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73496-014-01RoC Hydration Plus SPF 3050 mL in 1 BOTTLE, PUMPLOTION501
73496-014-02RoC Hydration Plus SPF 3050 mL in 1 TUBELOTION501

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 145 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfecting Blendrops Broad Spectrum SPF 40HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC12512cac-652e-b138-e063-6394a90ad1f22025-12-09WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEASHLEY SAMAI38f457fa-0e95-7298-e063-6394a90adda82025-12-09Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEOLGA KLIMOV INC387b41a4-057f-88af-e063-6394a90adbbe2025-12-09Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEOLGA KLIMOV INC387b8ae6-c48b-905c-e063-6394a90a31fb2025-12-09Exact identifier
application number: M020
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS36ea709b-3536-5052-e063-6394a90a48f92025-12-09Exact identifier
application number: M020
Age Defying Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b028159-f240-2cf2-e063-6294a90a32b52025-12-09WarningsExact identifier
application number: M020
Ultimate Mineral ProtectionZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b02bf69-b648-56e1-e063-6294a90aeef32025-12-09WarningsExact identifier
application number: M020
G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.01dcfd14-7a1d-98fa-e063-6294a90a03362025-12-09WarningsExact identifier
application number: M020
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS3aff2074-1514-b5c5-e063-6394a90a75722025-12-09Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER3729d270-64ac-4d2e-e063-6294a90aeb2c2025-12-09Exact identifier
application number: M020
Non Tinted Replenishing Daily ProtectionZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER372a41f6-40f6-4971-e063-6394a90a83e02025-12-09Exact identifier
application number: M020
Stay Shady Non-Tinted Mineral SunscreenZINC OXIDEAMOIE ALAYVILLA3b277237-3a2e-1fb0-e063-6294a90adf202025-12-09WarningsExact identifier
application number: M020
Stay Shady Non-Tinted Mineral SunscreenZINC OXIDEAMOIE ALAYVILLA3b27225f-4589-d915-e063-6294a90a72252025-12-09WarningsExact identifier
application number: M020
Replenishing Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC3738a0c3-5c07-e49b-e063-6394a90a38e92025-12-09Exact identifier
application number: M020
Replenishing Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC37385fc6-1cde-8aa6-e063-6294a90a60172025-12-09Exact identifier
application number: M020
Replenishing Tinted SunscreenZINC OXIDEBeauty Journey Studio LLC3738e5e0-f6d9-0568-e063-6294a90a67b62025-12-09Exact identifier
application number: M020
JAYSUING Matte Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456b44da-02f3-93a0-e063-6294a90a8d062025-12-08WarningsExact identifier
application number: M020
JAYSUING Matte Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456c2974-d499-7841-e063-6294a90a98eb2025-12-08WarningsExact identifier
application number: M020
JAYSUING Ginseng Moist Sun SerumTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456cfa70-f524-f5cb-e063-6394a90ae7dc2025-12-08WarningsExact identifier
application number: M020
Face and Body SunscreenNON-NANO ZINC OXIDE 25%Guangzhou Shengyanghui Industrial Trading Co., Ltd3ee96538-06e8-75b1-e063-6394a90a52852025-12-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73496-014-017349600140150 mL in 1 BOTTLE, PUMP (73496-014-01) 50 ml2025-12-08NoNoCurrent
73496-014-027349600140250 mL in 1 TUBE (73496-014-02) 50 ml2025-03-252028-03-31NoNoHistorical