MINERAL SUNSCREEN SPF 40 TINTED- titanium dioxide, zinc oxide cream

Mineral Sunscreen SPF 40 Tinted by

Drug Labeling and Warnings

Mineral Sunscreen SPF 40 Tinted by is a Otc medication manufactured, distributed, or labeled by Skin Restoration Aesthetics, Custom Analytics LLC, Fragrance Manufacturing Inc., Fallien Cosmeceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

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 medicalhelp or contact a Poison Control Center right away.

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:

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:

Protect this product from excessive heat and direct sun

May stain some fabrics

PA +++

Warning:

Keep out of the reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN SPF 40 TINTED 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85296-203(NDC:58892-203)
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85296-203-50	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/18/2024

Labeler - Skin Restoration Aesthetics (134407850)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85296-203)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85296-203)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85296-203)