COVERED- zinc oxide cream

COVERED by

Drug Labeling and Warnings

COVERED by is a Otc medication manufactured, distributed, or labeled by Potency No. 710 LLC, Fragrance Manufacturing Inc., Custom Analytics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Zinc Oxide 20%

Purpose:

Sunscreen

Uses:

Helps prevents 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.

Warnings:

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a poison control center right away.

Warnings:

Keep out of reach of children

Directions:

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: 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 am-2 pm Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

• Protect this product from excessive heat and direct sun.
• May stain some fabrics.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COVERED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85319-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
WATER (UNII: 059QF0KO0R)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85319-205-04	113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/28/2019

Labeler - Potency No. 710 LLC (100056294)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85319-205)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85319-205)