SPL v6
SPL
SPL Set ID 2179a2ff-9425-5b2c-e063-6294a90a45b6
Route
TOPICAL
Published
Effective Date 2024-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-06

Description

ACTIVE INGREDIENTS: Titanium Dioxide 4.0% 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. If swallowed,

get medical help or contact a Poison Control

Center right away.

Indications and Usage

DIRECTIONS:DIRECTIONS: Apply liberally 15 minutes before

sun exposure. Reapply: • After 80 mintues of

swimming or sweating • Immediately after towel

drying • 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 befor sun exposure.

Description

ACTIVE INGREDIENTS: Titanium Dioxide 4.0% Zinc Oxide 5.5%

Section 50565-1

Keep out of the reach of children.

Section 51727-6

INACTIVE INGREDIENTS: Alumina, Aluminum

Hydroxide, Aluminum Stearate, Ascorbic Acid,

Ascorbyl Palmitate, C12-15 Alkyl Benzoate,

Cetearyl Isononanoate, Cetyl PEG/PPG-15/15

Butyl Ether Dimethicone, Citric Acid, Ethylene

Brassylate, Ethylhexyl Palmitate, Helianthus

Annuus (Sunflower) Wax, Hexyldecanol,

Hexyldecyl Laurate, Iron Oxide, Lecithin,

Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate,

Polyhydroxystearic Acid, Propylene Glycol

Dicaprylate/Dicaprate, Stearic Acid,

Tocopherol, Tocopheryl Acetate, Zingiber

Officinale (Ginger) Root Oil

Section 51945-4

Principal Display Panel – 30g Cylinder Label

PROCEUTICALS

PRIVATE LABEL by TiZO

tinted mineral

sunscreen stick

broad spectrum spf 45

water resistant (80 minutes)

Net Wt. 1 oz. /30 g

Graphic-Untitled

Section 55105-1

PURPOSE:Sunscreen

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 55106-9

ACTIVE INGREDIENTS:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Section 60561-8

OTHER INFORMATION: • Protect this product

from excessive heat and direct sun • May stain

some fabrics


Structured Label Content

Indications and Usage (34067-9)

DIRECTIONS:DIRECTIONS: Apply liberally 15 minutes before

sun exposure. Reapply: • After 80 mintues of

swimming or sweating • Immediately after towel

drying • 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 befor 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, Aluminum

Hydroxide, Aluminum Stearate, Ascorbic Acid,

Ascorbyl Palmitate, C12-15 Alkyl Benzoate,

Cetearyl Isononanoate, Cetyl PEG/PPG-15/15

Butyl Ether Dimethicone, Citric Acid, Ethylene

Brassylate, Ethylhexyl Palmitate, Helianthus

Annuus (Sunflower) Wax, Hexyldecanol,

Hexyldecyl Laurate, Iron Oxide, Lecithin,

Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate,

Polyhydroxystearic Acid, Propylene Glycol

Dicaprylate/Dicaprate, Stearic Acid,

Tocopherol, Tocopheryl Acetate, Zingiber

Officinale (Ginger) Root Oil

Section 51945-4 (51945-4)

Principal Display Panel – 30g Cylinder Label

PROCEUTICALS

PRIVATE LABEL by TiZO

tinted mineral

sunscreen stick

broad spectrum spf 45

water resistant (80 minutes)

Net Wt. 1 oz. /30 g

Graphic-Untitled

Section 55105-1 (55105-1)

PURPOSE:Sunscreen

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 55106-9 (55106-9)

ACTIVE INGREDIENTS:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Section 60561-8 (60561-8)

OTHER INFORMATION: • Protect this product

from excessive heat and direct sun • May stain

some fabrics


Advanced Ingredient Data


Raw Label Data

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