SPL v1
SPL
SPL Set ID 1d611494-648b-6e5f-e063-6294a90a4500
Route
TOPICAL
Published
Effective Date 2024-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (55 mg) Titanium Dioxide (40 mg)
Inactive Ingredients
Aluminum Oxide .alpha.-tocopherol Acetate Aluminum Hydroxide Aluminum Stearate Ascorbic Acid Alkyl (c12-15) Benzoate Citric Acid Monohydrate Helianthus Annuus Seed Wax Hexyl Laurate Ferric Oxide Red Lecithin, Sunflower Polyethylene Glycol 400 Polyglyceryl-3 Diisostearate Polyhydroxystearic Acid (2300 Mw) Ascorbyl Palmitate Cetearyl Isononanoate Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Dipropylene Glycol Caprylate Kiwi Fruit Oil Hexyldecanol Ethylhexyl Palmitate Citrus Aurantiifolia Fruit Oil Ceresin Stearic Acid Tocopherol Ginger Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-16

Description

ACTIVE INGREDIENTS: Titanium Dioxide 4% Zinc Oxide 5.5%


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. Get medical help

or contact a Poison Control Center right away.

Indications and Usage

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

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 4% Zinc Oxide 5.5%

Section 50565-1

Keep out of the reach of

children.

Section 51727-6

INACTIVE INGREDIENTS:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate. Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Disostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oi

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 4%

Zinc Oxide 5.5%


Structured Label Content

Indications and Usage (34067-9)

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

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. 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, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate. Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Disostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oi

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 4%

Zinc Oxide 5.5%


Advanced Ingredient Data


Raw Label Data

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