DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (38 mg) Titanium Dioxide (80 mg)

Inactive Ingredients

Lauryl Peg/ppg-18/18 Methicone Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Aluminum Hydroxide Dimethicone 20 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Hydrogen Dimethicone (20 Cst) Cyclomethicone 6 Cyclomethicone 5 Peg-10 Dimethicone (600 Cst) Dimethiconol (2000 Cst)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-07-10

Medication Information

Warnings and Precautions

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 medical help or contact a Poison Control

Center right away.

Indications and Usage

DIRECTIONS:

• 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 and Administration

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.

Apply liberally 15 minutes before sun exposure.

Description

ACTIVE INGREDIENTS: Titanium Dioxide 8% Zinc Oxide 3.8%

Section 50565-1

Keep out of the reach of

children.

Section 51727-6

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

Section 51945-4

Principal Display Panel – 53 g Bottle Label

Proceuticals

PRIVATE LABEL by TiZO

non-tinted

mineral sunscreen

broad spectrum spf 40

water resistant (80 minutes)

net wt. 1.8 oz / 53 g

Graphic-Untitled

Section 55105-1

PURPOSE:Sunscreen

Section 55106-9

ACTIVE INGREDIENTS:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Section 60561-8

OTHER INFORMATION:

• Protect this product from excessive heat and direct sun

• PA ++++

Structured Label Content

Indications and Usage (34067-9)

DIRECTIONS:

• 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 and Administration (34068-7)

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.

Apply liberally 15 minutes before sun exposure.

Warnings and Precautions (34071-1)

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 medical help or contact a Poison Control

Center right away.

Section 50565-1 (50565-1)

Keep out of the reach of

children.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Principal Display Panel – 53 g Bottle Label

Proceuticals

PRIVATE LABEL by TiZO

non-tinted

mineral sunscreen

broad spectrum spf 40

water resistant (80 minutes)

net wt. 1.8 oz / 53 g

Graphic-Untitled

Section 55105-1 (55105-1)

PURPOSE:Sunscreen

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Section 60561-8 (60561-8)

OTHER INFORMATION:

• Protect this product from excessive heat and direct sun

• PA ++++

Advanced Ingredient Data

[{"name": "LAURYL PEG/PPG-18/18 METHICONE", "unii": "ZJ5S27D9NX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRAHEXYLDECYL ASCORBATE", "unii": "9LBV3F07AZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "38", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ALUMINUM HYDROXIDE", "unii": "5QB0T2IUN0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE 20", "unii": "H8YMB5QY0D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)", "unii": "UF7620L1W6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)", "unii": "9E4CO0W6C5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN DIMETHICONE (20 CST)", "unii": "12Z59IF64N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOMETHICONE 6", "unii": "XHK3U310BA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOMETHICONE 5", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-10 DIMETHICONE (600 CST)", "unii": "8PR7V1SVM0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONOL (2000 CST)", "unii": "T74O12AN6Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "DIRECTIONS: • 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", "34068-7": "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. Apply liberally 15 minutes before sun exposure.", "34071-1": "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 medical help or contact a Poison Control Center right away.", "50565-1": "Keep out of the reach of children.", "51727-6": "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", "51945-4": "Principal Display Panel – 53 g Bottle Label Proceuticals PRIVATE LABEL by TiZO non-tinted mineral sunscreen broad spectrum spf 40 water resistant (80 minutes) net wt. 1.8 oz / 53 g Graphic-Untitled", "55105-1": "PURPOSE:Sunscreen", "55106-9": "ACTIVE INGREDIENTS: Titanium Dioxide 8% Zinc Oxide 3.8%", "60561-8": "OTHER INFORMATION: • Protect this product from excessive heat and direct sun • PA ++++"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information