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

Mineral Sunscreen SPF 40 Non-Tinted by

Drug Labeling and Warnings

Mineral Sunscreen SPF 40 Non-Tinted by is a Otc medication manufactured, distributed, or labeled by Skin Restoration Aesthetics, 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

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, 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

PA ++++

Warning:

Keep out of the reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85296-202
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
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALUMINA (UNII: LMI26O6933)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85296-202-50	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
Fragrance Manufacturing Inc.		793406000	manufacture(85296-202)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85296-202)