82723-006

82723-006
SPL v2
SPL
SPL Set ID 202de881-ee58-81c5-e063-6394a90ae4c0
Routes
TOPICAL CUTANEOUS
Published
Effective Date 2024-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (19.5 g) Zinc Oxide (24 g)
Inactive Ingredients
Ferrosoferric Oxide Mica Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Stearic Acid Ferric Oxide Yellow Sodium Benzoate Potassium Sorbate Coconut Raspberry Seed Oil Carrot Seed Oil Rice Bran Kaolin Silica Dimethyl Silylate Mango Magnesium Stearate Tocopherol Aloe Vera Leaf Green Tea Leaf Chrysanthellum Indicum Top Lophatherum Gracile Leaf Lavender Oil Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-21

Description

Titanium dioxide-19.5% Zinc oxide-24%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide-19.5% Zinc oxide-24%

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 50567-7

When using this product: keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use

Stop use and ask a doctor if rash occurs.

Warnings

Flammable. Do not spray near heat sparks, sources of ignition, or flames.

Ask Doctor

Children under 6 months of age: ask a doctor.

Directions

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water

resistant sunscreen if swimming or sweating.

Package Label

label 82723-006-01

Other Information

Protect this product in this container from excessive heat and direct sun.

Active Ingredients

Titanium dioxide-19.5%

Zinc oxide-24%

Inactive Ingredients

Mica, Vinyl Dimethicone/Methicone,Silsesquioxane Crosspolymer, Sodium Benzoate. Potassium Sorbate,Coconut Scent, Kaolin, Tocopherol,Rubus idaeus (Raspberry) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil,Oryza Sativa (Rice) Powder,Silica Dimethyl Silylate, Mango Scent,Magnesium Stearate, Stearic Acid,Camellia Sinensis Extract, Aloe Barbadensis Leaf Powder,Chrysanthellum Indicum Extract,Lophatherum Gracile Leaf Powder,Lavandula Angustifolia (Lavender) Oil,Ci 77492, Ci 77491, Ci 77499

Keep Out of Reach of Children.

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


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 50567-7 (50567-7)

When using this product: keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs.

Warnings

Flammable. Do not spray near heat sparks, sources of ignition, or flames.

Ask Doctor (ASK DOCTOR)

Children under 6 months of age: ask a doctor.

Directions

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water

resistant sunscreen if swimming or sweating.

Package Label

label 82723-006-01

Other Information

Protect this product in this container from excessive heat and direct sun.

Active Ingredients

Titanium dioxide-19.5%

Zinc oxide-24%

Inactive Ingredients

Mica, Vinyl Dimethicone/Methicone,Silsesquioxane Crosspolymer, Sodium Benzoate. Potassium Sorbate,Coconut Scent, Kaolin, Tocopherol,Rubus idaeus (Raspberry) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil,Oryza Sativa (Rice) Powder,Silica Dimethyl Silylate, Mango Scent,Magnesium Stearate, Stearic Acid,Camellia Sinensis Extract, Aloe Barbadensis Leaf Powder,Chrysanthellum Indicum Extract,Lophatherum Gracile Leaf Powder,Lavandula Angustifolia (Lavender) Oil,Ci 77492, Ci 77491, Ci 77499

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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