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 187 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Blueberry Nutri Tint SPF 20 15N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L8d76a963-bdf5-44a1-b1d6-27d1a3aaa1ae2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 16N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.Ld279693f-2254-4f3c-a121-144f95f9f25d2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 12N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L7f007540-8271-4d85-9d1e-b2b273ca05f82025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 17W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L5198d3df-ffa8-45eb-93d1-11e9f3961b922025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 18N MediumZINC OXIDEDolce & Gabbana Beauty S.R.La82d85c4-c6ef-4083-b67a-2d6b0e8fc10d2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 19W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L4ee6cac6-f649-436c-ada2-e024b86add692025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 24N MediumZINC OXIDEDolce & Gabbana Beauty S.R.Ledd4e8c3-b47a-4cfe-bf20-e856edb76e212025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 21W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L457f0a5c-c543-44f8-82d6-1096a8aab9842025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 22N MediumZINC OXIDEDolce & Gabbana Beauty S.R.L1452ffc4-a83f-472f-ae70-9e1002f889452025-09-08WarningsExact identifier
application number: M020
Ocean Potion Suncare 50 Continuous Sunscreen Scent of SunshineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3e518d8a-f52b-4ae1-e063-6394a90aaa1e2025-09-08WarningsExact identifier
application number: M020
Ocean Potion Suncare 50 Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3c5a624a-8844-b782-e063-6294a90a478c2025-09-08WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dbb07e2-971c-284d-e063-6294a90a437f2025-09-06WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3e069cb2-c4c5-abf5-e063-6394a90a56b02025-09-06WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 2C LightZINC OXIDEDolce & Gabbana Beauty S.R.L761ce50c-2bf5-4ed0-91ac-9c47f8790ddb2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 3W LightZINC OXIDEDolce & Gabbana Beauty S.R.L2781b921-eb0d-4270-addf-47301577b28c2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 5N LightZINC OXIDEDolce & Gabbana Beauty S.R.L893434a1-72b8-4f0f-bfaa-2c9d775d7e272025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 7N LightZINC OXIDEDolce & Gabbana Beauty S.R.L199d97a2-d32b-45ab-a43d-30522b0ca5962025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 10N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L638eafb5-08a8-425f-893f-d6609b868e2b2025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 9C Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L41fd80a9-2c6f-4f3e-a37d-e781965ddc552025-09-05WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 11W Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L50bac9fb-5b81-4cdd-9eae-ec9530fc46c32025-09-05WarningsExact 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