California Tan
FDA Label NDC 58443-0097

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises, Inc. for the product California Tan (NDC 58443-0097). 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 principal display panel - 133 ml  tube label, active ingredients, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Principal Display Panel - 133 Ml  Tube Label

Principal Display Panel (133 mL Tube Label)

Principal Display Panel (133 mL Tube Label)

CALIFORNIA TAN

CT

45

SUNSCREEN LOTION

Broad Spectrum SPF 45

Water Resistant

(80 Minutes)

CLEANTOUCH

TECHNOLOGY

133 mL / 4.5 Fl Oz

Active Ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.7 %, and Oxybenzone 2 %

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

Warnings

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 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 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-sleeve shirts, pants, hats, and sunglasses
      • children under 6 months: Ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine Cyclic Phosphate, Adenosine Triphosphate, Butylated Hydroxytoluene, Butylphthalimide, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Coelus Forskohlii Extract, Disodium EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isopropylphthalimide, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Methylparaben, Micrococcus Lysate, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyethylene, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Water (Aqua)

Other Information

  • protect this product from excesive heat and direct sun

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