FDA.reportPublic FDA data

RoC Hydration Plus SPF 30 Lotion

Manufacturer
Roc Skincare
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:22:12

Label at a glance#

ProductRoC Hydration Plus SPF 30
Active ingredientOCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE
Label structure10 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun,...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

For external use only

Do not useon damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove. Stop use and ask a doctorif rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions For Sunscreen Use:

DOSAGE & ADMINISTRATION SECTION

  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Pentylene Glycol, Dimethicone, Octyldodecanol, Caprylyl Methicone, Propanediol, Potassium Cetyl Phosphate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hyaluronic Acid, 1,2-Hexanediol, Hydrolyzed Sodium Hyaluronate, Biosaccharide Gum-4, Jasminum Sambac (Jasmine) Leaf Cell Extract, Glycerin, Dibutyl Lauroyl Glutamide, Carbomer, Aminomethyl Propanol, Dibutyl Ethylhexanoyl Glutamide, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylhydroxamic Acid, Disodium EDTA, Fragrance/Parfum.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-RoC-1964 (1-800-762-1964)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

CartonCarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GlassGlassCartonCarton

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73496-01473496-014-01, 73496-014-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYALURONATE SODIUMYSE9PPT4THIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
PENTYLENE GLYCOL50C1307PZGIACT
OCTYLDODECANOL461N1O614YIACT
PROPANEDIOL5965N8W85TIACT
HYALURONIC ACIDS270N0TRQYIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
DIBUTYL ETHYLHEXANOYL GLUTAMIDE0IAF2L30VSIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
BIOSACCHARIDE GUM-49XRL057X90IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
DIBUTYL LAUROYL GLUTAMIDE3V7K3IA58XIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
JASMINUM SAMBAC FLOWER2S686I937FIACT
CARBOMER0A5MM307FCIACT
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoC Hydration Plus SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoc Skincare45a3e250-8195-344d-e063-6294a90ae6812025-12-10WarningsExact identifier
ndc (package): 73496-014-01
ndc (package): 73496-014-02
ndc (product): 73496-014
ndc11 (package): 73496001402
ndc11 (package): 73496001401
spl id: 45a3e259-aa75-67c1-e063-6294a90a850a
spl set id: 45a3e250-8195-344d-e063-6294a90ae681

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.