DailyMed - COVERED- zinc oxide cream

NDC Code(s): 85319-205-15
Packager: Potency No. 710 LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 24, 2025

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Active Ingredients:
Zinc Oxide 20%

Zinc Oxide 20%
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Purpose:
Sunscreen

Sunscreen
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Warning:
For external use only

For external use only
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Warning:
For external use only - Keep out of reach of children

For external use only

Keep out of reach of children
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Warning:
Keep out of reach of children

Keep out of reach of children
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Directions:
Apply liberally 15 minutes before sun exposure

Apply liberally 15 minutes before sun exposure
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INACTIVE INGREDIENT
C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl ...

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
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OTHER SAFETY INFORMATION
SAMPLE NOT FOR RESALE

SAMPLE NOT FOR RESALE
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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

Product Information

COVERED zinc oxide cream

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:85319-205-15	1.5 g in 1 PACKET; Type 0: Not a Combination Product	03/18/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	03/18/2021

Labeler - Potency No. 710 LLC (100056294)

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

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

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COVERED- zinc oxide cream

Number of versions: 1

COVERED- zinc oxide cream

COVERED- zinc oxide cream

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COVERED- zinc oxide cream

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.