Label at a glance#

ProductSHADED

Active ingredientTITANIUM DIOXIDE, ZINC OXIDE

Label structure9 sections

Indications and 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.

Dosage and administration

• 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...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8% Zinc Oxide 3.8%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

• 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 Ingredietns:

INACTIVE INGREDIENT SECTION

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 Information:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.
May stain some fabrics.
Cleanse thoroughly at nighttime.
PA +++

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0385319201851	GTIN-13: 0385319201851 EAN-13: 0385319201851 GTIN-12: 385319201851 UPC-A: 385319201851 GTIN storage (14 digits): 00385319201851	Potency 710 SHADED 201.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85319-201-85	SHADED	85 g in 1 BOTTLE, PUMP	CREAM	85		2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

SHADED
Titanium Dioxide, Zinc Oxide
CYCLOHEXASILOXANE
ALUMINA
CYCLOPENTASILOXANE
TITANIUM DIOXIDE
ZINC OXIDE
DIMETHICONE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
DIMETHICONOL (2000 CST)
CI 77491
CI 77492
PEG-10 DIMETHICONE (600 CST)
LAURYL PEG/PPG-18/18 METHICONE
ALPHA-TOCOPHEROL ACETATE
DIMETHICONE CROSSPOLYMER
TETRAHEXYLDECYL ASCORBATE
CI 77499
HYDROGEN DIMETHICONE (20 CST)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85319-201	85319-201-85
58892-201

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CYCLOHEXASILOXANE	XHK3U310BA	IACT
ALUMINA	LMI26O6933	IACT
CYCLOPENTASILOXANE	0THT5PCI0R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
DIMETHICONE	92RU3N3Y1O	IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)	9E4CO0W6C5	IACT
DIMETHICONOL (2000 CST)	T74O12AN6Y	IACT
CI 77491	1K09F3G675	IACT
CI 77492	EX438O2MRT	IACT
PEG-10 DIMETHICONE (600 CST)	8PR7V1SVM0	IACT
LAURYL PEG/PPG-18/18 METHICONE	ZJ5S27D9NX	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
DIMETHICONE CROSSPOLYMER	UF7620L1W6	IACT
TETRAHEXYLDECYL ASCORBATE	9LBV3F07AZ	IACT
CI 77499	XM0M87F357	IACT
HYDROGEN DIMETHICONE (20 CST)	12Z59IF64N	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SHADED	TITANIUM DIOXIDE, ZINC OXIDE	Potency No. 710 LLC	31177bbd-68b0-8b24-e063-6294a90aa8d8	2025-12-10	Warnings	Exact identifier ndc (package): 85319-201-85 ndc (product): 85319-201 ndc11 (package): 85319020185 spl id: 459bde25-f541-9aa4-e063-6394a90a6cb1 spl set id: 31177bbd-68b0-8b24-e063-6294a90aa8d8
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen Backbar	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	2be9f92a-a041-0595-e063-6394a90af7a8	2025-01-17	Warnings	Exact identifier ndc (product): 58892-201

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.