Active Ingredients
Avobenzone 2%
Homosalate 7.5%
Octisalate 5%
Octocrylene 2.75%
Oxybenzone 2%
California Tan
FDA Label NDC 13630-0112
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 13630-0112). 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 ingredients, purpose, uses, warnings, otc - do not use, 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
Purpose
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
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it
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.
Other
Flammable: Do not use near heat, flame or while smoking.
Directions
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- hold container 4 to 6 inches from the skin to apply
- do not spray directly into face. Spray on hands then apply to face
- do not apply in windy conditions
- use in a well-ventilated area
- reapply:
- after 80 minutes of swimming and 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 Ingredient
Adenosine Cyclic Phosphate, Adenosine Triphosphate, Camellia Sinensis (Green Tea) Leaf Extract, Coleus Forskohlii Extract, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Lycium Barbarum (Goji Berry) Fruit Extract, Micrococcus Lysate, Phospholipids, Plant Amino Acids, Polyester-8, Polyperfluoroethoxymethoxy Difluorohydroxyethyl PEG Phosphate, Propylene Glycol, Pyruvic Acid, Saccharomyces Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces Magnesium Ferment, Saccharomyces Zinc Ferment, Alcohol Denat., VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water (Aqua)
Other Information
- protect this product from excessive heat and direct sun
- avoid spraying on fabrics - could cause discoloration
Question Or Comments?
Call toll free 1-800 SUNCARE
California Tan Contiuous Sunscreen Broad Spectrum Spf 30
Principal Display Image (13630 0112 4)
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