SPL v1
SPL
SPL Set ID 396393c4-b50c-3877-e063-6294a90a0e9b
Route
CUTANEOUS
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (8 g) Water (35 g)
Inactive Ingredients
Titanium Dioxide Aloe Barbadensis Leaf Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Cucumis Sativus (cucumber) Seed Daucus Carota Sativa (carrot) Juice Agave Tequilana Leaf Caprylic/capric Triglyceride Carthamus Tinctorius (safflower) Oleosomes Cetearyl Alcohol Coco-glucoside Tocopherol Niacinamide Ethylhexylglycerin Maltose Sodium Hyaluronate Glycerin Hydrolyzed Jojoba Esters

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-07-08
Description

Water,Zinc Oxide

Medication Information

Warnings and Precautions

Keep out of reach of children

Indications and Usage

Sun protection

Dosage and Administration

1.69 FL.OZ/50 ML

Description

Water,Zinc Oxide

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51727-6

Titanium Dioxide,Agave Tequilana Leaf Extract,Aloe Barbadensis Extract,Cucumis Sativus (Cucumber) Fruit Extract

Sativa (Carrot) Extract,Caprylic/Capric Triglyceride,Carthamus Tinctorius (Saflower) Oleosomes,Rose Damascena (Rose) Exract

Cetearyl Alcohol,Coco-glucoside,Glycerin,Hydrolyzed Wheat Protein,Iron Oxides,Jojoba Esters,Maltose

Sodium Hyaluronate,Tocopherol,Niacinamide,Ethylhexylglycerin

Section 51945-4

Section 55105-1

Sun protection

Section 55106-9

Water,Zinc Oxide

Structured Label Content

Indications and Usage (34067-9)

Sun protection

Dosage and Administration (34068-7)

1.69 FL.OZ/50 ML

Warnings and Precautions (34071-1)

Keep out of reach of children

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51727-6 (51727-6)

Titanium Dioxide,Agave Tequilana Leaf Extract,Aloe Barbadensis Extract,Cucumis Sativus (Cucumber) Fruit Extract

Sativa (Carrot) Extract,Caprylic/Capric Triglyceride,Carthamus Tinctorius (Saflower) Oleosomes,Rose Damascena (Rose) Exract

Cetearyl Alcohol,Coco-glucoside,Glycerin,Hydrolyzed Wheat Protein,Iron Oxides,Jojoba Esters,Maltose

Sodium Hyaluronate,Tocopherol,Niacinamide,Ethylhexylglycerin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sun protection

Section 55106-9 (55106-9)

Water,Zinc Oxide

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:04.656600 · Updated: 2026-03-14T23:17:26.215261