FDA.reportPublic FDA data

Roderm Protecting SPF Lotion

Manufacturer
Roman Health Ventures Inc.
Effective date
2021-11-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:29

Label at a glance#

ProductRoderm Protecting SPF 28 Sunscreen
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, Suite 706A

New York, NY 10003

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

roderm
Protecting SPF Lotion

Broad Spectrum SPF 28 Sunscreen

1.66 fl oz (50 mL)

Ro Derm SPF28 12-2021Ro Derm SPF28 12-2021

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72484-203-01Roderm Protecting SPF 28 Sunscreen30 mL in 1 BOTTLE, PLASTICLOTION301
72484-203-01Roderm Protecting SPF 28 Sunscreen1 in 1 CARTONLOTION11
72484-203-02Roderm Protecting SPF 28 Sunscreen50 mL in 1 BOTTLE, PLASTICLOTION501
72484-203-02Roderm Protecting SPF 28 Sunscreen1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72484-203RODERM PROTECTING SPF 28 SUNSCREEN (OCTINOXATE, ZINC OXIDE) LOTION [ROMAN HEALTH VENTURES INC.]1Legacy NDC, 4 package rows20211208_d08a33a5-ed84-6316-e053-2a95a90a80e2.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
72484-20372484-203-01, 72484-203-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
POLYGONUM AVICULARE WHOLEM990N03611IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
COCONUT OILQ9L0O73W7LIACT
EDETATE DISODIUM7FLD91C86KIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-100 STEARATEYD01N1999RIACT
CETYL DIMETHICONE 1505L694Y0T22IACT
ISOCETYL STEARATE3RJ7186O9WIACT
WATER059QF0KO0RIACT
OCTINOXATE4Y5P7MUD51ACTIB
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
VACCINIUM VITIS-IDAEA FRUIT OIL16Y54799WZIACT
LEPIDIUM SATIVUM WHOLE0FL88F2R2QIACT
SORBITOL506T60A25RIACT
ETHYL MACADAMIATEANA2NCS6V1IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
XANTHAN GUMTTV12P4NEEIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
QUERCUS SUBER BARK8R5219271QIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
OCTISALATE4X49Y0596WIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLUCONOLACTONEWQ29KQ9POTIACT
CALCIUM GLUCONATESQE6VB453KIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
VITIS VINIFERA FRUIT OILYQ5Q4Y2Z8UIACT
SODIUM BENZOATEOJ245FE5EUIACT
QUERCUS SPP. WHOLEMF4E5I2OUQIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CENTELLA ASIATICA7M867G6T1UIACT
ISOMALTS870P55O2WIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT

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
d08a33a5-ed85-6316-e053-2a95a90a80e2d08a33a5-ed84-6316-e053-2a95a90a80e22021-11-11WarningsExact identifier
spl id: d08a33a5-ed85-6316-e053-2a95a90a80e2
spl set id: d08a33a5-ed84-6316-e053-2a95a90a80e2

Reported adverse events (FAERS/openFDA)#

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