TITANIUM DIOXIDE: 63 Adverse Event Reports & Safety Profile

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Total FAERS Reports

13 (20.6%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Chipican LLC

Manufacturer

Route: TOPICAL · Manufacturer: Chipican LLC · HUMAN OTC DRUG · FDA Label: Available

First Report: 2003 · Latest Report: 20240625

What Are the Most Common TITANIUM DIOXIDE Side Effects?

#1 Most Reported

Hypersensitivity

12 reports (19.0%)

#2 Most Reported

Reaction to excipient

9 reports (14.3%)

#3 Most Reported

Dyspnoea

8 reports (12.7%)

All TITANIUM DIOXIDE Side Effects by Frequency

Side Effect	Reports	% of Total	Deaths	Hosp.
Hypersensitivity	12	19.1%	0	0
Reaction to excipient	9	14.3%	0	6
Dyspnoea	8	12.7%	3	3
Abdominal pain upper	6	9.5%	0	0
Madarosis	6	9.5%	0	0
Nausea	6	9.5%	2	2
Pain in extremity	6	9.5%	0	6
Restless legs syndrome	6	9.5%	0	6
Acne	5	7.9%	0	0
Drug hypersensitivity	5	7.9%	3	3
Dry mouth	5	7.9%	2	2
Rash	5	7.9%	0	1
Swelling face	5	7.9%	0	0

Who Reports TITANIUM DIOXIDE Side Effects? Age & Gender Data

Gender: 55.8% female, 44.2% male. Average age: 64.5 years. Most reports from: US. View detailed demographics →

Is TITANIUM DIOXIDE Getting Safer? Reports by Year

Year	Reports	Deaths	Hosp.
2003	1	0	0
2007	1	0	0
2011	1	0	0
2014	1	0	0
2015	3	0	0
2016	2	0	1
2017	4	0	0
2018	9	0	6
2019	1	0	0
2020	11	6	6
2024	1	0	0

View full timeline →

What Is TITANIUM DIOXIDE Used For?

Indication	Reports
Product used for unknown indication	26
Constipation	13

Official FDA Label for TITANIUM DIOXIDE

Official prescribing information from the FDA-approved drug label.

Drug Description

This B.B. Cream creates a lustrous, flawless finish as it hydrates, firms and soothes the skin. Helps diminish the appearance of pores, fine lines and uneven skintone while providing long-wearing, natural coveage that conceals imperfections. Abyssine, a naturally-derived survival molecule, shields and soothes skin while Hydroxyprolisilane promotes skin elasticity and reduces the appearance of fine lines. Beta-Glucon provides essential moisture and protects against environmental damage. Preservative-free. Dermatologist tested. Alcohol-free, pH balanced, 100% artificial fragrance and color free. No animal testing and no animal ingredients. www.boscia.net B210-01 Distributed by boscia, LLC. Irvine, CA 92614 Made in U.S.A. B11-1

FDA Approved Uses (Indications)

DIRECTIONS:

Shake well before using.
Press nozzle carefully during first use
Apply liberally 15 minutes before sun exposure.
Reapply:
After 40 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

Dosage & Administration

Drug Facts Active Ingredients Active Ingredient Purpose Titanium Dioxide 6.4% Sunscreen Zinc Oxide 15.0% Sunscreen Uses Helps prevent sunburn Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Children under 6 months of age: 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 a.m.-2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

1,2-Hexanediol, Alumina, Aqua/Water/Eau, Ascorbic Acid, Beta-Glucan, Bisabolol, Butylene Glycol, Calcium Chloride, Cetyl PEG/PPG-10/1 Dimethicone, Cordyceps Militaris Mycelium Extract, Dimethicone, Dimethicone Crosspolymer, Erythritol, Ethylhexylglycerin, Glycerin, Glycine Soja (Soybean)

Seed

Extract, Glycyrrhiza Uralensis (Licorice)

Root

Extract, Hexyl Laurate, Homarine HCL, Iron Oxides, Lactobacillus Ferment, Melanin, PEG-10 Dimethicone, Pentylene Glycol, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethyl Methacrylate, Potassium Sorbate, Retinyl Palmitate, Scutellaria Baicalensis Root Extract, Silica, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Sodium Citrate, Squalane, Stearic Acid, Tocopheryl Acetate, Tribehenin.

FDA Boxed Warning

BLACK BOX WARNING

Drug Facts

Warnings

WARNINGS Warnings: For external use only. Do not use on damaged or broken skin Avoid prolonged sun exposure. If it gets in your eyes, wash well with water. Keep out of reach of children. Stop use and ask a doctor if rashes occur. If product is swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours. Children under 3 years of age: 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 10.00AM - 2.00PM Wear long-sleeved shirts, pants, hats, and sunglasses

Precautions

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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a physician.

Active Ingredient

active ingredients Purpose Titanium Dioxide 8% Sunscreen Uses · helps prevent sunburn · Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. · Stop use and ask a doctor if rash occurs and persists WARNINGS Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove.

Directions For

Sunscreen use · Apply liberally 15 minutes before sun exposure · Reapply at least every 2 hours · Use a water resistant sunscreen if swimming or sweating · Children under 6 months of age: Ask a doctor ISODODECANE,ISOHEXADECANE, ZINC OXIDE (CI 77947), IRON OXIDES ,BUTYLENE/ETHYLENE/PROPYLENE COPOLYMER , SILICA ,DISTEARDIMONIUM HECTORITE, POLYMETHYL METHACRYLATE,TALC,POLYGLYCERYL - 3 DIISOSTEARATE , POLYETHYLENE, RETINYL PALMITATE, TOCOPHERYL ACETATE, TETRAHEXYLDECYL ASCORBATE , TRI ETHOXYCAPRYLYLSILANE , PROPYLENE CARBONATE, ETHYLEN E B RASSYLATE, BENZYL ALCOHOL

Inactive Ingredients

Inactive Ingredients NDCs 82141-2357-1, 82141-2358-1, 82141-2360-1, 82141-2363-1 Hydrogenated Polyisobutene; Ethylhexyl Palmitate; Nylon-12; Paraffin; Hydrogenated Microcrystalline Wax; Polymethyl Methacrylate; Mica; Butylene Glycol Cocoate; Methyl Methacrylate Crosspolymer; Carnauba (Copernica cerifera) Wax; Silica; Hydrogenated Castor Oil; Alumina, Squalene, Calaguala (Polypodium leucotomos)