Determination of the Sun Protection Factor (SPF) of a Cosmetic Daily De-fence Skin Cream

Inclusion Criteria

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
• Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination
• Subjects with a Fitzpatrick Skin Type of I, II or III
• Subjects with an Individual typological angle (ITA°) greater than 28°

Exclusion Criteria

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
• Women who are breast-feeding or lactating
• Subjects having used medication with known photo-toxic and/or photosensitizing potential (e.g. hypericum perforatum, antibiotics, blood pressure regulating agents) up to 14 days prior to screening
• Subjects with a history of systemic therapy with anti-inflammatory agents or analgesics (e.g. diclofenac) up to 3 days prior to screening
• Subjects with dermatological conditions
• Subjects with a history of abnormal response to the sun
• Subjects who are tanned or have had sun exposure on the back area in the previous 4 weeks prior to screening
• Subjects having marks, blemishes or nevi or presenting existing sun damage in the test area
• Subjects having excessive hair, moles, tattoos, scars or other imperfections in the test area that could influence the investigation
• Subjects with a history of systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. anti-allergics) up to 7 days prior to screening
• Subjects with a non-uniform skin colour or hyperpigmentation in the test area
• Subjects with a medical history of dysplastic nevi or melanoma
• Subjects with one of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer
• Subjects with asthma, unless medicated
• Subjects with an electronic implant (e.g. pace maker, insulin pump, hearing aid) that cannot be removed during irradiation
• Acquired immune deficiency syndrome (AIDS) and infectious hepatitis, if known to the subjects
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Known allergy to latex
• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days prior to screening
• Participation in another clinical study involving UV exposure to the same test site up to 2 months prior to screening
• Previous participation in this study
• Recent history (within the last 5 years) of alcohol or other substance abuse
• Subjects who have used a tanning bed or other tanning treatment on the back area up to 1 month prior to screening
• Subjects accustomed to using tanning beds
• Subjects who have used self-tanning products on the back area in the previous 1 month prior to screening
• An employee of the sponsor or the study site or members of their immediate family
• Subjects who will turn 71 years old before completing all assessment visits