DERMASHIELD- titanium dioxide, octinoxate cream cream

DermaShield by

Drug Labeling and Warnings

DermaShield by is a Otc medication manufactured, distributed, or labeled by USRX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENT:

• TITANIUM DIOXIDE 2%
• OCTINOXATE 7%

Sunscreen

FOR EXTERNAL USE ONLY

DO NOT USE - On damaged or broken skin

STOP USE AND ASK A DOCTOR IF A RASH OCCURRS

INACTIVE INGREDIENTS:

INGREDIENTS AND APPEARANCE

DERMASHIELD 
titanium dioxide, octinoxate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70809-1901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SORBITOL (UNII: 506T60A25R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
METHICONE (20 CST) (UNII: 6777U11MKT)
CETYL ALCOHOL (UNII: 936JST6JCN)
OCTISALATE (UNII: 4X49Y0596W)
DIMETHICONE (UNII: 92RU3N3Y1O)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70809-1901-1	90 mL in 1 TUBE; Type 0: Not a Combination Product	07/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/08/2019

Labeler - USRX LLC (115270633)

Registrant - USRX LLC (115270633)