California Tan
FDA Label NDC 13630-0078

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 Packaging, Inc. for the product California Tan (NDC 13630-0078). 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 - 142 g can label, active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - 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

Principal Display Panel - 142 G Can Label

Principal Display Panel (142g Can Label)

Principal Display Panel (142g Can Label)

California Tan

CT

45

Face

Mousse

Sunscreen Mousse

Broad Spectrum SPF 45

Water Resistant

(80 Minutes)

OIL FREE • FRAGRANCE-FREE

Net Wt. 5 oz (142g)

Active Ingredients

Avobenzone 3 %, Homosalate 15%, Octisalate 5 %, and Octocrylene 2.75 %

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if use 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. Contents under pressure-do not puncture or incinerate. Do not store at temperatures above 120°F

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 and spread evenly by hand 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/C12-22 Alkyl Methacrylate Cocolymer, Adenosine Cyclic Phesphate, Adenosine Triphosphate, Allantoin, Aloe Barbadensis Leaf Juice, Butane, Butylene Glycol, Camelllia Sinensis (Green Tea) Leaf Extract, Ceteareth-20, Cetearyl Alcohol, Chamomilla Recitita (Matricaria) Flower Extract, Coleus Forskohlii Root Extract, Disodium EDTA, EDTA, Glucose, Hydrolyzed Soy Protein, Isostearic Acid, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Methylparaben, Micrococcus Lysate, Phenoxyethanol, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyperfluoroethoxymethoxy Difluoroethyl PEG Phosphate, Polysorbate 20, Polysorbate 60, Propane, Propylene Glycol, Pyruvic Acid, Quaternium-15, Saccharomyces/Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces/Magnesium Ferment, Saccharomyces/Zinc Ferment, Sodium Polyacrylate, Stearic Acid, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other Information

  • protect this product from exessive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration

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