FDA.reportPublic FDA data

RoC - Hydration Plus Moisturizer SPF 30

Manufacturer
Roc Skincare | Dermaceutical Laboratories Limited Liability Company
Effective date
2025-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:37:34

Label at a glance#

ProductRoC - Hydration Plus Moisturizer SPF 30
Active ingredientOCTOCRYLENE, OCTISALATE, HOMOSALATE, AVOBENZONE
Label structure9 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 use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if 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, Hyaluronic Acid, Potassium Cetyl Phosphate, Ammonium Acryloyldimethyltaurate/VP Copolymer, 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, 1,2-Hexanediol, Disodium EDTA, Fragrance/Parfum.

Questions or Comments?

OTC - QUESTIONS SECTION

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

Carton Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73496-012ROC - HYDRATION PLUS MOISTURIZER SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [ROC SKINCARE]1Unmatched20250529_362034e9-282f-19a5-e063-6394a90a8dfb.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73496-01273496-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
PENTYLENE GLYCOL50C1307PZGIACT
OCTYLDODECANOL461N1O614YIACT
PROPANEDIOL5965N8W85TIACT
HYALURONIC ACIDS270N0TRQYIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
DIBUTYL ETHYLHEXANOYL GLUTAMIDE0IAF2L30VSIACT
AVOBENZONEG63QQF2NOXACTIB
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

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
45a3fd54-1f15-8450-e063-6294a90aaf9b362034e9-282f-19a5-e063-6394a90a8dfb2025-12-10WarningsExact identifier
spl set id: 362034e9-282f-19a5-e063-6394a90a8dfb

Reported adverse events (FAERS/openFDA)#

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