Roman Broad Spectrum SPF 28

Manufacturer
Roman Health Ventures Inc.
Effective date
2020-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:24

Label at a glance#

ProductRoman Broad Spectrum SPF 28 Sunscreen Face Moisturizer
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Octinoxate 7%

Zinc Oxide 6%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Use

Helps prevent sunburn.

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age: ask a doctor
  • 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

OTHER SAFETY INFORMATION

Other information

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Isocetyl Stearate, Cetyl Dimethicone, Styrene/Acrylates Copolymer, Sorbitol, Ethyl Macadamiate, Cetearyl Alcohol, Dimethicone, Acrylates/Dimethicone Copolymer, Phenoxyethanol, Glyceryl Stearate, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Ceteareth-10, Ethylhexyl Salicylate, VP/Eicosene Copolymer, Xanthan Gum, Polymethyl Methacrylate, Caprylyl Glycol, Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Vaccinium Vitis-Idaea Fruit Extract, Quercus Suber Bark Extract, Triethoxycaprylylsilane, Camellia Sinensis Leaf Extract, Disodium EDTA, Tocopheryl Acetate, Oak Root Extract, Centella Asiatica Extract, Polygonum Aviculare Extract, Citric Acid, Gluconolactone, Isomalt, Calcium Gluconate, Lecithin, Vitis Vinifera (Grape) Fruit Cell Extract, Sodium Benzoate, Lepidium Sativum Sprout Extract.

SPL UNCLASSIFIED SECTION

Distributed by:

Roman Health Ventures, Inc.

900 Broadway Street, Suite #706

New York, NY 10003

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

roman
Weightless Face Moisturizer

Broad Spectrum SPF 28 Sunscreen

2 fl oz (60 mL)

Roman Moisturizer 07_27_20Roman Moisturizer 07_27_20

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72484-201-032023-01-30C16284748780-1f386c64a-157e-0266-e053-dadaa90a7c1aRoman Sunscreen Face Moisturizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72484-201-03Roman Broad Spectrum SPF 28Sunscreen Face Moisturizer60 mL in 1 BOTTLE, PLASTICLOTION601
72484-201-03Roman Broad Spectrum SPF 28Sunscreen Face Moisturizer1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72484-201ROMAN BROAD SPECTRUM SPF 28 SUNSCREEN FACE MOISTURIZER (OCTINOXATE, ZINC OXIDE) LOTION [ROMAN HEALTH VENTURES INC.]1Legacy NDC, 2 package rows20200801_ab855368-c7e9-0cc3-e053-2a95a90a16f2.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72484-20172484-201-03

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

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
ab855368-c7ea-0cc3-e053-2a95a90a16f2ab855368-c7e9-0cc3-e053-2a95a90a16f22020-07-28WarningsExact identifier
spl id: ab855368-c7ea-0cc3-e053-2a95a90a16f2
spl set id: ab855368-c7e9-0cc3-e053-2a95a90a16f2

Reported adverse events (FAERS/openFDA)#

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