FDA Amendment 21 CFR Part 1040, Effective May 1980

(d) Label requirements. In addition to the labeling requirements in Part 801 of this chapter and the certification and identification requirements of 1010.2 and 1010.3 of this chapter, each sunlamp product and ultraviolet lamp shall be subject to the labeling requirements prescribed in this paragraph and paragraph (f) of this section. All labels prescribed in this paragraph shall be permanently affixed or inscribed on an exterior surface of the product so as to be legible and readily accessible to view when the product is fully assembled for use.

(1) Each sunlamp product shall have a label which contains:

(i) The words "DANGER—Ultraviolet radiation. Follow instructions. As with natural sunlight, overexposure can cause eye injury and sunburn; repeated exposure may cause premature aging of the skin and skin cancer. Medications or cosmetics applied to the skin may increase your sensitivity to ultraviolet light. Consult physician before using lamp if taking any medication or if you believe yourself especially sensitive to sunlight."

(ii) Designation of the ultraviolet lamp type which is to be used in the product.

(iii) A recommended minimum use distance specified both in meters and in feet (or in inches).

(iv) Directions for measuring the minimum use distance.

(v) A warning that exposure at distances less than the minimum use distance is not recommended.

(vi) A warning to use protective eyewear whenever the product is energized.

(vii) A recommended maximum exposure time in minutes.

(viii) A recommendation for duration, frequency and spacing of sequential exposures.

(ix) A statement of the time it may take before the expected results appear.

(2) Each ultraviolet lamp shall have a label which contains:

(i) The words "Sunlamp-DANGER—Ultraviolet radiation. Follow instructions."

(ii) The model identification.

(iii) The words "Use ONLY in fixture equipped with a timer."

(3) In lieu of permanently affixing or inscribing tags or labels on the ultraviolet lamp as required by 1010.2(b) and 1010.3(a) of this chapter, the manufacturer of the ultraviolet lamp may permanently affix or inscribe such required tags or labels on the lamp packaging uniquely associated with the lamp, if the name of the manufacturer and month and year of manufacture are permanently affixed or inscribed on the exterior surface of the ultraviolet lamp so as to be legible and readily accessible to view. When the tags or labels required by 1010.2(b) and 1010.3(a) of this chapter are affixed or inscribed on the ultraviolet lamp packaging, the name of the manufacturer and month and year of manufacture required to be permanently affixed or inscribed on the exterior surface of the lamp may be expressed in code or symbols, if the manufacturer has previously supplied the Director, Bureau of Radiological Health, with the key to such code or symbols and the location of the coded information or symbols on the ultraviolet lamp.