Zinc Oxide 20% Lotion
FDA Label NDC 69630-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Soleil Group, Llc for the product Zinc Oxide 20% (NDC 69630-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient                                                        purpose zinc oxide 20% .......................................................sunscreen, uses, directions, warnings for external use only., keep out of reach of children., inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                                        Purpose Zinc Oxide 20% .......................................................Sunscreen

Uses

Helps prevent sunburn . If used as directed with other
sun protection measures (see Directions), decreases the risk
of skin cancer and early skin aging caused by the sun.

Directions

Apply evenly to face and neck 15 minutes before sun
exposure reapply: After 80 minutes of swimming or sweating .
Immediately after towel drying . At least every 2 hours • Sun Protection
Measures.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 value of 15 or higher and other sun
protection measures including: Limit time in the sun, especially from
10a.m.– 2p.m. . Wear long-sleeve shirts, pants, hats, and sunglasses.
. Children under 6 months: Ask a doctor.

Warnings For External Use Only.

Do not useon damaged or broken skin.
When using this product• keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor ifrash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact Poison Control Center right away

Inactive Ingredients

Aloe Barbadensis Leaf Juice,
Aluminum Starch Octenylsuccinate,
Bisabolol,
Caprylic/Capric Triglyceride,
Capryloyl Glycerin/Sebacic Acid Copolymer,
Caprylyl Carbonate,
Diheptyl Succinate,
Ethylhexylglycerin,
Galactoarabinan,
Glycerin,
Glyceryl Stearate SE,
Helianthus Annuus (Sunflower) Seed Oil,
Jojoba Esters,
Magnesium Sulfate,
Mica,
Niacinamide,
Octyldodecanol,
Phenoxyethanol,
Polyglyceryl-2 Distearate,
Polyhydroxystearic Acid,
Porphyra Umbilicalis Extract,
Sodium Hyaluronate,
Squalane Oil,
Tetrahexyldecyl Ascorbate,
Tocopheryl Acetate,
Triethoxycaprylylsilane,
Trihydroxystearin,
Tripeptide-5,
VP/Hexadecene Copolymer,
Water,
Iron Oxide Red (CI 77491),
Tin Oxide (CI 77861),
Titanium Dioxide (CI 77891)

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