DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (85.4 mg) Zinc Oxide (40.7 mg)

Inactive Ingredients

Aluminum Oxide Cyclomethicone 5 Dimethicone Ferric Oxide Red

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2007-05-21

Medication Information

Purpose

Sunscreen

Description

DRUG FACTS

Uses:

Helps prevent 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.

Section 42229-5

DRUG FACTS

Section 50565-1

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product, keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51945-4

Principal Display Panel – Carton Label

NDC 58892-326-20

SOLAR

PROTECTION

FORMULA ^®

TIZO ₃ ^® protection

Facial Mineral Fusion

SPF 40

Broad Spectrum

Water Resistant

(80 minutes)

1.5 Fl. Oz./ 44.4 ml

Warnings:

For external use only.

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 10:00 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information:

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

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimothiconol, Iron Oxide (CI77491), Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone

Structured Label Content

Uses:

Helps prevent 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.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product, keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

Principal Display Panel – Carton Label

NDC 58892-326-20

SOLAR

PROTECTION

FORMULA ^®

TIZO ₃ ^® protection

Facial Mineral Fusion

SPF 40

Broad Spectrum

Water Resistant

(80 minutes)

1.5 Fl. Oz./ 44.4 ml

Purpose

Sunscreen

Warnings:

For external use only.

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 10:00 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information:

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

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimothiconol, Iron Oxide (CI77491), Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone

Advanced Ingredient Data

[{"name": "Titanium Dioxide", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "85.4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Zinc Oxide", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "40.7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Aluminum Oxide", "unii": "LMI26O6933", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Cyclomethicone 5", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Dimethicone", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Ferric Oxide Red", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses:": "Helps prevent 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.", "42229-5": "DRUG FACTS", "50565-1": "Keep out of the reach of children . If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs.", "50567-7": "When using this product , keep out of eyes. Rinse with water to remove.", "50570-1": "Do not use on damaged or broken skin.", "51945-4": "Principal Display Panel – Carton Label NDC 58892-326-20 SOLAR PROTECTION FORMULA ® TIZO 3 ® protection Facial Mineral Fusion SPF 40 Broad Spectrum Water Resistant (80 minutes) 1.5 Fl. Oz./ 44.4 ml", "Purpose": "Sunscreen Sunscreen", "Warnings:": "For external use only.", "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 10:00 a.m.-2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses", "Other Information:": "Protect this product from excessive heat and direct sun May stain some fabrics Cleanse thoroughly at nighttime", "Active Ingredients:": "Titanium Dioxide 8% Zinc Oxide 3.8%", "Inactive Ingredients:": "Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimothiconol, Iron Oxide (CI77491), Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information