RODERM PROTECTING SPF 28 SUNSCREEN- octinoxate, zinc oxide lotion 
Roman Health Ventures Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Roderm Protecting SPF Lotion

Drug Facts

Active ingredients

Octinoxate 7%

Zinc Oxide 6%

Purpose

Sunscreen

Use

Helps prevent sunburn.

Warnings

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 a Poison Control Center right away.

Directions

Other information

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

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.

Distributed by:

Roman Health Ventures, Inc.

900 Broadway, Suite 706A

New York, NY 10003

roderm
Protecting SPF Lotion

Broad Spectrum SPF 28 Sunscreen

1.66 fl oz (50 mL)

Ro Derm SPF28 12-2021

RODERM PROTECTING SPF 28 SUNSCREEN 
octinoxate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72484-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYGONUM AVICULARE WHOLE (UNII: M990N03611)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
COCONUT OIL (UNII: Q9L0O73W7L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
WATER (UNII: 059QF0KO0R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
VACCINIUM VITIS-IDAEA FRUIT OIL (UNII: 16Y54799WZ)  
LEPIDIUM SATIVUM WHOLE (UNII: 0FL88F2R2Q)  
SORBITOL (UNII: 506T60A25R)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
QUERCUS SUBER BARK (UNII: 8R5219271Q)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
OCTISALATE (UNII: 4X49Y0596W)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
QUERCUS SPP. WHOLE (UNII: MF4E5I2OUQ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ISOMALT (UNII: S870P55O2W)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72484-203-011 in 1 CARTON11/11/2021
130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:72484-203-021 in 1 CARTON11/11/2021
250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/11/2021
Labeler - Roman Health Ventures Inc. (081317350)

Revised: 11/2021
Document Id: d08a33a5-ed85-6316-e053-2a95a90a80e2
Set id: d08a33a5-ed84-6316-e053-2a95a90a80e2
Version: 1
Effective Time: 20211111
 
Roman Health Ventures Inc.