FDA.reportPublic FDA data

Avobenzone, Homosalata, Octisalate, Octocrylene

Manufacturer
Roc Skincare | Dermaceutical Laboratories Limited Liability Company
Effective date
2021-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:19:51

Label at a glance#

ProductROC MULTI CORREXION 5-In-1 Daily Moisturizer With Sunscreen Broad Spectrum SPF 30
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, 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 15 or higher and other sun protection measures including: Limit time in the sun, especial...

Storage and handling

Protect this product from excessive heat and direct sun May stain some fabrics

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 2.0%.......Sunscreen

Uses

OTC - PURPOSE 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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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 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
  • May stain some fabrics

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Ethylhexyl Salicylate, Glycerin, Homosalate, Isononyl Isononanoate, Dimethicone, Steareth-2, Ascorbyl Glucoside, Butyl Methoxydibenzoylmethane, Ethylhexyl Palmitate, Octocrylene, Steareth-21, Propanediol, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Methyl Methacrylate Crosspolymer, Behenyl Alcohol, Hexylresorcinol, Sclerotium Gum, Dimethicone Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Caprylhydroxamic Acid, 1,2-Hexanediol, Sodium Hydroxide, Disodium EDTA, Fragrance, Mica, Titanium Dioxide (CI 77891).

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-RoC-1964 (1-800-762-1964) or 215-273-8755 (collect).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Artwork-CartonLabel Artwork-Carton

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73496-00673496-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
DOCOSANOL9G1OE216XYIACT
DIMETHICONE92RU3N3Y1OIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
SODIUM HYDROXIDE55X04QC32IIACT
HEXYLRESORCINOLR9QTB5E82NIACT
PROPANEDIOL5965N8W85TIACT
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
STEARETH-2V56DFE46J5IACT
STEARETH-2153J3F32P58IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
AVOBENZONEG63QQF2NOXACTIB
BETASIZOFIRAN2X51AD1X3TIACT
PEG-8 LAURATE762O8IWA10IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
SHEA BUTTERK49155WL9YIACT
ETHYLHEXYL PALMITATE2865993309IACT
MICAV8A1AW0880IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
EDETATE DISODIUM7FLD91C86KIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
f0710a0a-9590-ea65-e053-2a95a90ae6f9d4780e38-4b13-1d0a-e053-2a95a90a73582022-12-22WarningsExact identifier
spl set id: d4780e38-4b13-1d0a-e053-2a95a90a7358

Reported adverse events (FAERS/openFDA)#

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