RODERM PROTECTING SPF 28 SUNSCREEN- octinoxate, zinc oxide lotion

Roderm Protecting SPF 28 Sunscreen by

Drug Labeling and Warnings

Roderm Protecting SPF 28 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Roman Health Ventures Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Octinoxate 7%

Zinc Oxide 6%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Use

Helps prevent sunburn.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

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

PRINCIPAL DISPLAY PANEL

roderm
Protecting SPF Lotion

Broad Spectrum SPF 28 Sunscreen

1.66 fl oz (50 mL)

INGREDIENTS AND APPEARANCE

RODERM PROTECTING SPF 28 SUNSCREEN 
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72484-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72484-203-01	1 in 1 CARTON	11/11/2021
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 72484-203-02	1 in 1 CARTON	11/11/2021
2		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/11/2021

Labeler - Roman Health Ventures Inc. (081317350)