SPL v1
SPL
SPL Set ID 4b50f047-3a69-4194-8e56-bd3c49b4c540
Route
TOPICAL
Published
Effective Date 2011-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (5.52 g) Zinc Oxide (1.569 g) Octinoxate (2.8 g) Amiloxate (0.4 g) Arbutin (0.8 g) Adenosine (0.016 g)
Inactive Ingredients
Brown Iron Oxide Chlorphenesin Disodium Edta-copper Methylparaben Propylparaben

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, Disodium EDTA, Iron Oxide, Methylparaben, Propylparaben

Section 51945-4
Section 55105-1
Purpose: Sunscreen

Section 55106-9
Active Ingredients: Adenosine 0.04%, Arbutin 2.00%, Octinoxate 7.00%, Amiloxate 1.00%, Titanium Dioxide 13.80%, Zinc Oxide 3.92%

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, Disodium EDTA, Iron Oxide, Methylparaben, Propylparaben

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

Section 55106-9 (55106-9)
Active Ingredients: Adenosine 0.04%, Arbutin 2.00%, Octinoxate 7.00%, Amiloxate 1.00%, Titanium Dioxide 13.80%, Zinc Oxide 3.92%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:22.923667 · Updated: 2026-03-14T22:52:56.035859