Sunscreen
Sugared+Bronzed Tinted Sunscreen
1444c150-3c8e-a9f9-e063-6394a90a5d9e
HUMAN OTC DRUG LABEL
Jul 6, 2025
CA-Botana International
DUNS: 106276728
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zinc Oxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (32)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Indications & Usage
Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Zinc Oxide 21%............................................. Sunscreen
OTC - PURPOSE SECTION
Purpose
Sunscreen
OTHER SAFETY INFORMATION
Safety information
Protect this product from excessive heat and direct sun
OTC - ASK DOCTOR SECTION
Ask Doctor
Stop use and ask a doctor if rash occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
Keep out of reach of children
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Water (Aqua), Coco-Caprylate/Caprate, Ceteary Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Cetearyl Olivate, Sorbitan Olivate, Caprylhydroxamic acid. GlycerylCaprylate, Glycerin, Xanthan Gum, Equisetum arvense (Horsetail) extract, Rosmarinus officinalis (Rosemary) extract, Centella asiatica(Gotu-kola) extract, Aesculus hippocastanum (Horse chestnut) extract, Camellia sinensis(Green tea) extract, Olea europaea (Olive) extract, Tocopheryl Acetate, Potassium Sorbate, Sodium Phytate, Carthamus tinctorius (Safflower ) Seed oil, Silica, Triethoxycapryylsilane, OXY CA (Rosmarinus officnalis (Leaf)CO2 Extract& Ascorbyl Palmitate & Caprylic/Capric Triglyceride & Ascorbic Acid & Tocopherol & Citric Acid ), Glyceryl Stearate, Iron Oxide.
DOSAGE & ADMINISTRATION SECTION
Dosage & Administration
Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Usea water resistant sunscreen if swimming or sweating. Reapply : at least 2 hours. Children under 6 months: Ask a doctor. Sun protections measurements. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and othe sun protection measures including: limit time in the sun, specially from 10 a.m.- 2 p.m Wear long-sleeveshirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun.
WARNINGS SECTION
Warnings
For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. If product is swallowed get medical help or contact a poison Control Center right away.