Solar Defense Tinted Cream
FDA Label NDC 60934-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hydropeptide Llc for the product Solar Defense Tinted (NDC 60934-005). 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 drug facts, active ingredients, purpose, uses, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Titanium Dioxide (2.5%)

Zinc Oxide (6%)

Purpose

Sunscreen

Uses

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

Do Not Use

on damaged or broken skin.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

if rash occurs.

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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 suncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor

Inactive Ingredients

Water, Ethylhexyl palmitate, Propanediol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Glycerin, Sodium PCA, Dimethicone, Thermus Thermophilus Ferment, Polysorbate 60, Glyceryl Stearate, PEG-100 Stearate, Titanium Dioxide, Hydroxyethly Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetyl Alcohol, Boron Nitride, Calendula Officinalis Flower Extract, Camellia Oleifera Leaf Extract, Caprylyl Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Cyclomethicone, Sodium Citrate, 1,2-Hexanediol, Caprylyl Methicone, Alumina, Allantoin, Aloe Barbadensis Leaf Juice, Chlorphenesin, Kaempferia Galanga Root Extract, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Xanthan Gum, Triethoxycaprylylsilane, Cucumis Sativus (Cucumber) Fruit Extract, Disodium EDTA, Euterpe Oleracea Fruit Extract, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Panthenol, Sodium Hyaluronate, Acrylates/Ammonium Methacrylate Copolymer, Biotin, Cellulose Acetate, Hydrolyzed Yeast Protein, Magnesium Stearate, Niacinamide, Pentylene Glycol, Polyhydroxystearic Acid, Propylene Glycol Stearate, Pyridoxine HCL, Limonene, Linalool, Benzyl Benzoate, Benzyl Salicylate, Butylphenyl Methylpropional, Citral, Hexyl Cinnamal, Methyl Lonone Gamma, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499), Propylene Glycol, Butylene Glycol

Other Information

Protect the product in this container from excessive heat and direct sun.

Questions Or Comments?

Call 1.800.932.9873

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