SHADED- titanium dioxide, zinc oxide cream

SHADED by

Drug Labeling and Warnings

SHADED 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:

Titanium Dioxide 8% Zinc Oxide 3.8%

Purpose:

Sunscreen

Warning:

For External Use Only

Warning:

• For External Use Only
• Keep Out of Reach of Children

Warning:

Keep out of reach of children

Directions:

Apply liberally 15 minutes before sun exposure

INACTIVE INGREDIENT

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

OTHER SAFETY INFORMATION

SAMPLE NOT FOR RESALE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHADED 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85319-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	38 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINA (UNII: LMI26O6933)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CI 77491 (UNII: 1K09F3G675)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CI 77499 (UNII: XM0M87F357)
CI 77492 (UNII: EX438O2MRT)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85319-203-15	1.5 g in 1 PACKET; Type 0: Not a Combination Product	05/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/18/2020

Labeler - Potency No. 710 LLC (100056294)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85319-203)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85319-203)