High-protection broad-spectrum sunscreen lotion (Class I medical device)
Certifications
European Class I medical device with CE marking for prevention of certain forms of non Melanoma skin cancer in at Risk patients.
Formulated and manufactured under medical device quality and regulatory requirements (originally by Spirig Pharma Ltd., now part of Galderma).
Broad Spectrum UVA/UVB protection meeting high Protection criteria according to EU recommendations and Australian Standard for UVA performance.
European Class I medical device with CE marking for prevention of certain forms of non Melanoma skin cancer in at Risk patients.
Formulated and manufactured under medical device quality and regulatory requirements (originally by Spirig Pharma Ltd., now part of Galderma).
Broad Spectrum UVA/UVB protection meeting high Protection criteria according to EU recommendations and Australian Standard for UVA performance.
Clinical evidence in immunosuppressed organ transplant patients demonstrating reduction in actinic keratoses and prevention of new invasive squamous cell carcinoma with regular use.
Description
DAYLONG ACTINICA LOTION 80ml (Actinica Lotion) is a Class I CE-marked medical device developed by Galderma for people at increased risk of non-melanoma skin cancer due to UV exposure. It is a Swiss-made, broad-spectrum, photostable sunscreen lotion with very high protection against UVA and UVB rays, designed for daily long-term use on sun-exposed skin. Clinical data in immunosuppressed high-risk patients have shown that regular daily application over two years can significantly reduce actinic keratoses and help prevent the development of certain forms of non-melanoma skin cancer, including squamous cell carcinoma. The lotion is water resistant, moisturising, fragrance-free and PEG-emulsifier-free, making it suitable for sensitive skin.
Bnefits
Provides very high, broad-spectrum protection against both UVB and UVA radiation using modern photostable filters.
Clinically demonstrated efficacy in reducing actinic keratoses and preventing new invasive squamous cell carcinoma in high-risk, immunosuppressed patients when used regularly over two years.
Indicated for prevention of certain forms of non-melanoma skin cancer (e.g. actinic keratosis and squamous cell carcinoma) in at-risk patients.
Water resistant formulation provides sustained protection during everyday activities and moderate water exposure or sweating.
Moisturises and conditions the skin, helping to counteract UV- and heat-induced dehydration.
Fragrance-free and free of traditional PEG emulsifiers, improving tolerability and allowing use on very sensitive skin.
Broad-spectrum photostable filters help maintain consistent protection over time under UV exposure.
Standardised dosing pump (dispenser bottle) delivers a precise, reproducible dose per pump for correct application.
Suitable for face and body and can be used all year round as part of a daily routine.
Class I European medical device status ensures compliance with stricter regulations than cosmetic sunscreens regarding safety, quality and clinical data.
Indications
Prevention of certain forms of non-melanoma skin cancer (NMSC) in high-risk, particularly immunosuppressed patients (e.g. organ transplant recipients).
Clinical evidence in immunosuppressed organ transplant patients demonstrating reduction in actinic keratoses and prevention of new invasive squamous cell carcinoma with regular use.
High-protection broad-spectrum sunscreen lotion (Class I medical device)
Prevention and reduction of actinic keratoses in chronically sun-exposed skin.
Prevention of invasive squamous cell carcinoma in high-risk patients as part of comprehensive photoprotection.
Protection of very sun-sensitive or previously UV-damaged skin requiring very high, broad-spectrum protection.
Daily photoprotection for fair-skinned individuals and those with chronic or occupational sun exposure.
Adjunctive protection in patients with photodermatoses (e.g. polymorphous light eruption) where high-level broad-spectrum protection is recommended.
Butyl Methoxydibenzoylmethane (Avobenzone) – key organic UVA filter providing protection across UVA1 and UVA2.
Propylparaben – preservative (and minor perfuming function).
Methylparaben – preservative.
Additional dermocosmetic excipients forming a liposomal/cream-lotion vehicle (emollients, humectants, stabilisers), formulated without fragrance and without conventional PEG emulsifiers.
Formulation
Medical-grade sunscreen lotion (cream-lotion) with liposomal technology for very high UV protection.
SPF 50+ equivalent high UVB protection, with broad-spectrum UVA protection that meets or exceeds Australian Standard requirements.
Non-perfumed, PEG-emulsifier-free, photostable formula suitable for sensitive skin.
Water resistant, moisturising texture designed for daily use on face and body.
Organic (chemical / hybrid) UV filter system, free of mineral (zinc oxide / titanium dioxide) filters.
Pack size 80 g / 80 ml dispenser bottle with standardised metered pump.
Packaging
80 ml dispenser bottle with dosing pump designed to deliver a standardised amount of lotion per pump.
Face and body lotion presentation for daily use on all uncovered skin areas.
Outer cardboard box (varies by market) with full labelling, instructions for use and medical device information.
Class I medical device labelling, including CE mark and manufacturer details (Galderma / Spirig).
Usage
Apply Daylong Actinica (Actinica Lotion) every morning throughout the year to all areas of skin that will be exposed to UV light and are not covered by clothing.
Apply liberally to ensure adequate dosing (e.g. approximately 2 mg/cm²; roughly 0.5 teaspoon for face and neck, and about 1.5 teaspoons for both arms, as per dose tables in the instructions for use). Using less than the recommended amount significantly reduces the level of protection.
Apply 20–30 minutes before first UV exposure and before applying other cosmetic products; allow the lotion to be absorbed into the skin for a few minutes before using make-up or other skincare.
Reapply after prolonged contact with water, heavy sweating, or towel drying, especially during outdoor activities.
Use every day as part of the daily routine, even on cloudy days or when the sun is not visibly shining, to maintain continuous protection.
Immunosuppressed and other high-risk patients should, in addition to using Actinica Lotion, wear protective clothing (tightly woven fabrics), UV-protective sunglasses and a wide-brimmed hat, and avoid direct midday sun when possible.
Avoid contact with the eyes; if the lotion accidentally gets into the eyes, rinse thoroughly with plenty of water.
If used together with insect repellent, apply Actinica Lotion first, wait approximately 15 minutes for it to absorb, then apply the repellent. Be aware that in this situation the sun protective effect may be somewhat reduced.
Do not apply immediately before dressing to reduce the risk of staining clothing or certain materials, as UV filters can cause discolouration of textiles and plastics.
Discontinue use and consult a healthcare professional if marked irritation, rash, or a sunburn-like reaction occurs after short UV exposure, as this may indicate an adverse reaction to one of the ingredients.
Contraindications
Known hypersensitivity or allergy to any of the active UV filters, parabens, or other excipients contained in the product.
Presence of acute skin irritation, active dermatitis, infection or open wounds on the intended application site unless advised by a healthcare professional.
History of severe reactions to chemical sunscreens with similar filter systems, unless a physician has assessed suitability.
Not intended for use directly in the eyes or on mucous membranes; avoid application to these areas.
Caution in individuals with a history of photosensitivity reactions to any of the listed UV filters; medical supervision is advisable.
Adverse Effects
Possible transient skin reactions such as redness, itching, burning or stinging, particularly in sensitive individuals or when first starting use.
Occasional development of irritation, rash or a sunburn-like reaction after brief UV exposure, which may indicate an adverse reaction to one of the ingredients; in such cases use should be stopped and an alternative product considered.
Potential for cosmetic staining or discolouration of clothing, plastics and other materials if skin is not fully dry before contact.
As with other topical products, very rare risk of allergic contact dermatitis due to UV filters or preservatives in susceptible individuals.
Storage Conditions
Store at room temperature in a cool, dry place away from direct sunlight and excessive heat.
Keep the container tightly closed when not in use to protect the product from contamination and degradation.
Do not expose the bottle to extreme temperatures (e.g. in a very hot car or in freezing conditions).
Keep out of the reach of children.
Use within the expiry date indicated on the packaging and observe any specific period-after-opening guidance provided by the manufacturer.
Duration
Intended for long-term, daily use all year round as part of a continuous photoprotection strategy; clinical studies have evaluated regular use over a period of 24 months in high-risk, immunosuppressed patients.
Onset
Photoprotective effect is immediate once an adequate amount of lotion has been correctly applied and absorbed (within approximately 20\u201330 minutes before UV exposure); clinical benefits in reducing actinic keratoses and preventing non-melanoma skin cancer accrue gradually with consistent daily use over months to years.
