SPL v3
SPL
SPL Set ID 30468afc-9616-4765-b046-12e97a0a7827
Route
TOPICAL
Published
Effective Date 2010-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (85.4 mg) Zinc Oxide (40.7 mg)
Inactive Ingredients
Aluminum Oxide Cyclomethicone 5 Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2009-03-01 Until 2024-12-31

Description

DRUG FACTS

Purpose

Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

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 58892-336-45

SOLAR

PROTECTION

FORMULA
®

TIZO 2 ® protection

Facial Mineral Fusion

for Light Skin Tones

SPF 40

Broad Spectrum

Water Resistent

(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
Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimothiconol, 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 58892-336-45

SOLAR

PROTECTION

FORMULA
®

TIZO 2 ® protection

Facial Mineral Fusion

for Light Skin Tones

SPF 40

Broad Spectrum

Water Resistent

(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
Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimothiconol, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone


Advanced Ingredient Data


Raw Label Data

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