SPL v1
SPL
SPL Set ID 2836734d-bde8-4e12-89e7-2ef429e12906
Route
TOPICAL
Published
Effective Date 2011-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.6 g) Zinc Oxide (2.52 g) Arbutin (0.8 g) Adenosine (0.016 g)
Inactive Ingredients
Propylparaben Chlorphenesin Carbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-12-01
Description

Purpose: Sunscreen

Medication Information

Warnings and Precautions
Warnings: For external use only.  Do not use other than directed.  Keep the lid back on after using

Description
Direction:  

Step 1: Clean and dry your face

Step 2: Use the basic skincare products

Step 3: Use small amount of it and apply evenly and thoroughly to your face

                

Section 44425-7
Storage: Keep in a cool, dry place away from heat and direct sunlight

Section 50565-1
Keep Out of Reach of Children: If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9
Stop Use: Please stop using this product and contact a dermatologist.

                1. If red rash, swelling, itch or irritation occurs

                2. If direct sunlight affects the area as above

Section 50567-7
When using this product: Do not use other than directed

Section 50570-1
Do Not Use: On wounds, rashes, dermatitis or damaged skin

Section 51727-6
Inactive Ingredients: Chlorphenesin, Propylparaben

Section 51945-4
Section 55105-1
Purpose: Sunscreen

Section 55106-9
Active Ingredients: Titanium Dioxide 9.01%, Zinc Oxide 6.30%, Arbutin 2%, Adenosine 0.04%

Structured Label Content

Warnings and Precautions (34071-1)
Warnings: For external use only.  Do not use other than directed.  Keep the lid back on after using

Description (34089-3)
Direction:  

Step 1: Clean and dry your face

Step 2: Use the basic skincare products

Step 3: Use small amount of it and apply evenly and thoroughly to your face

                

Section 44425-7 (44425-7)
Storage: Keep in a cool, dry place away from heat and direct sunlight

Section 50565-1 (50565-1)
Keep Out of Reach of Children: If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9 (50566-9)
Stop Use: Please stop using this product and contact a dermatologist.

                1. If red rash, swelling, itch or irritation occurs

                2. If direct sunlight affects the area as above

Section 50567-7 (50567-7)
When using this product: Do not use other than directed

Section 50570-1 (50570-1)
Do Not Use: On wounds, rashes, dermatitis or damaged skin

Section 51727-6 (51727-6)
Inactive Ingredients: Chlorphenesin, Propylparaben

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose: Sunscreen

Section 55106-9 (55106-9)
Active Ingredients: Titanium Dioxide 9.01%, Zinc Oxide 6.30%, Arbutin 2%, Adenosine 0.04%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:22.955207 · Updated: 2026-03-14T22:52:56.035859