DermShield by USRX LLC DermShield SPF 30

DermShield by

Drug Labeling and Warnings

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

Drug Details [pdf]

DERMSHIELD- titanium dioxide, octinoxate cream cream 
USRX LLC

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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DermShield SPF 30

ACTIVE INGREDIENT:

• TITANIUM DIOXIDE 2%
• OCTINOXATE 7%

Sunscreen

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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 A RASH OCCURRS

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

FOR EXTERNAL USE ONLY

Diretions

• Apply to all skin exposed to the sun
• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours.
• For children under 6 moths 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 the risk, regularly use a sunscreen with a BroadSpectrum 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.

INACTIVE INGREDIENTS:

ISOCETYL STEARATE, SORBITOL, CETEARYL ALCOHOL, CETEARETH-20, TOCOPHERYL ACETATE, ACETYL HEXAPEPTIDE-0, HYDROLYZED RICE PROTEIN, ALCOHOL SDA-40, DIMETHICONE, OCTYL SALICYLATE, CETYL ALCOHOL METHICONE, SODIUM LAURETH SULFATE, CARBOMER, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, FRAGRANCE, TRETHANOLAMINE, STEARIC ACID, LECITHIN, CAPRYLYL GLYCOL, METHYLISOTHIAZOLINONE.

DERMSHIELD 
titanium dioxide, octinoxate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70809-1909
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: 70809-1909-1	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	10/01/2022

Labeler - USRX LLC (115270633)

Registrant - USRX LLC (115270633)

Revised: 10/2021

Document Id: cea65832-405c-1200-e053-2995a90abb4c

34390-5

Set id: aa07b232-0413-0a6a-e053-2a95a90a04f7

Version: 2

Effective Time: 20211018