84484-001

84484-001
SPL v1
SPL
SPL Set ID 3c4a3b41-9183-3835-e063-6394a90aea61
Route
CUTANEOUS
Published
Effective Date 2025-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15 g) Titanium Dioxide (10 g)
Inactive Ingredients
Rubus Idaeus (raspberry) Seed Oil Hydrogenated Castor Oil Hydroxyacetophenone Hexylene Glycol Dipotassium Glycyrrhizate Allantoin Chamomile Water Caprylic/capric Triglyceride Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Glycerin Sorbitan Sesquioleate Magnesium Sulfate Tocopherol Sodium Hyaluronate Citrus Paradisi (grapefruit) Peel Oil Centella Asiatica Root Carica Papaya (papaya) Fruit

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-14

Description

Zin Oxide 1 5.% Titanium Dioxide 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zin Oxide 1 5.% Titanium Dioxide 10%

Use

Use Protect UVA and UVB rays and support sun protection.

Section 50565-1

Keep out of 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 irrita tion or rash develops and continues for more than 72 hours.

Section 50567-7

When using this product do not get into eyes. if contact occurs, rinse thoroughly with water.

Warnings

For external use only.

Directions

Adults and children 2 years and over:Apply sunscreen 15 minutes on skin before sun exposure.

Children under2 years: Ask doctor before use.

Do Not Use

DO not use if you are allergic to any of the ingredient.

Other Information

No

Active Ingredient(s)

Zin Oxide 1 5.%

Titanium Dioxide 10%

Inactive Ingredients

Purified Water, Caprylic/Capric Triglyceride, Cety| Peg/Ppg-10/1 Dimethicone, Glycerin, Sorbitan Sesquioleate,

Magnesium Sulfate, Tocopherol, Sodium Hyaluronate, Allantoin, Dipotassium Glycyrrhizate,

Chamomilla Recutita Flower E xtract, Citrus Paradisi (Grapefruit) Peel Oil, Centella Asiatica Root Extract,

Rubus ldaeus (Raspberry) Seed Oil, Carica Papaya (Papaya) Fruit Extract, Hydrogenated Castor Oil,

Hydroxyacetophenone, Hexylene Glycol.

Package Label Principal Display Panel


Structured Label Content

Use

Use Protect UVA and UVB rays and support sun protection.

Section 50565-1 (50565-1)

Keep out of 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 irrita tion or rash develops and continues for more than 72 hours.

Section 50567-7 (50567-7)

When using this product do not get into eyes. if contact occurs, rinse thoroughly with water.

Purpose

Sunscreen

Warnings

For external use only.

Directions

Adults and children 2 years and over:Apply sunscreen 15 minutes on skin before sun exposure.

Children under2 years: Ask doctor before use.

Do Not Use (Do not use)

DO not use if you are allergic to any of the ingredient.

Other Information (Other information)

No

Active Ingredient(s)

Zin Oxide 1 5.%

Titanium Dioxide 10%

Inactive Ingredients (Inactive ingredients)

Purified Water, Caprylic/Capric Triglyceride, Cety| Peg/Ppg-10/1 Dimethicone, Glycerin, Sorbitan Sesquioleate,

Magnesium Sulfate, Tocopherol, Sodium Hyaluronate, Allantoin, Dipotassium Glycyrrhizate,

Chamomilla Recutita Flower E xtract, Citrus Paradisi (Grapefruit) Peel Oil, Centella Asiatica Root Extract,

Rubus ldaeus (Raspberry) Seed Oil, Carica Papaya (Papaya) Fruit Extract, Hydrogenated Castor Oil,

Hydroxyacetophenone, Hexylene Glycol.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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