title: The impact of natural sunlight exposure on the UVB-sun protection factor (UVB-SPF) and UVA protection factor (UVA-PF) of a UVA/UVB SPF 50 sunscreen.
abstract: OBJECTIVE
  To compare the functional stability of Cetaphil UVA/UVB Defense SPF 50 as measured by its ultraviolet B sun protection factor (UVB-SPF) and ultraviolet A protection factor (UVA-PF) values following exposure to natural sunlight versus the UVB-SPF and UVA-PF values of unexposed product.
  
  
  METHODS
  These two randomized, controlled, evaluator-blinded, single-center trials were conducted according to the methods outlined in the 2007 Proposed Amendment to the Final Monograph, “Sunscreen Drug Products for Over-the-Counter Human Use.” Sunscreen samples were applied to glass plates and exposed to ultraviolet radiation in the form of natural sunlight in four minimal erythemal doses (MED) ranging from 2–6 MED (42–36 mJ/cm2). Three test sites were identified on the back of each study subject. Exposed sunscreen (one of four doses), unexposed sunscreen, and a UVB-SPF 15 control sunscreen were applied to the three test sites in a randomized fashion, followed by UV irradiation of incremental doses. Erythema and pigment darkening responses were assessed immediately following UV exposure and again 16–24 hours (erythema) or three to 24 hours (pigment darkening) after exposure. UVB-SPF and UVA-PF values were calculated for the exposed and unexposed samples.
  
  
  RESULTS
  The calculated UVB-SPF and UVA-PF values for all test samples (exposed and unexposed) were >50 and >9, respectively, which were greater than the stated UVB-SPF and UVA-PF values on the product label. No differences were observed between the exposed and unexposed samples in UVB-SPF or UVA-PF.
  
  
  CONCLUSIONS
  The UVA and UVB protection using standard evaluation techniques of Cetaphil UVA/UVB Defense SPF 50 remains stable despite exposure of the sunscreen to natural sunlight containing UVB ranging from 2–16 MED (41–336 mJ/cm2) and coexistent UVA.
authors.affiliation: Thomas J. Stephens & Associates, Inc., Carrollton, TX, USA.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Stephens
authors.forename: James H
authors.initials: JH
authors.lastname: Herndon
authors.forename: Luz E
authors.initials: LE
authors.lastname: Colón
authors.forename: Ronald W
authors.initials: RW
authors.lastname: Gottschalk
mesh_terms: D004338:Drug Combinations; D004890:Erythema / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D011356:Product Labeling; D011409:Propylene Glycols; D012867:Skin; D012967:Sodium Dodecyl Sulfate; D016082:Solar System; D013471:Sunburn / Q000517:prevention & control*; D013472:Sunlight; D013473:Sunscreening Agents / Q000009:adverse effects / Q000494:pharmacology*; D055107:Suntan; D016896:Treatment Outcome; D014466:Ultraviolet Rays / Q000009:adverse effects*
chemical_list: D004338:Drug Combinations; D011409:Propylene Glycols; D013473:Sunscreening Agents; C011189:cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion; D012967:Sodium Dodecyl Sulfate