BiafineAct Emulsion – Burns, Minor Irritations

For: Children (30+ months), Adolescents, Adults
Pregnancy: Safe
Breastfeeding: Safe
Form: Emulsion
Size: 139.5g tube

Description

BiafineAct is a soothing emulsion designed for the treatment of minor burns, localized sunburns, and superficial skin irritations. It also helps promote healing of non-infected skin wounds.

This dermatological treatment contains Trolamine (0.67%), known for its calming and moisturizing properties that help restore damaged skin. Its rich, creamy texture provides immediate relief and hydration to the affected area.

Active Ingredients

Trolamine 0.67% (active ingredient)
Other ingredients: Ethylene glycol stearate, stearic acid, cetyl palmitate, solid paraffin, liquid paraffin, perhydrosqualene, propylene glycol, avocado oil, trolamine and sodium alginate, potassium sorbate, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), Yerbatone fragrance, purified water.

How to Use

• For minor burns and localized sunburns: apply a thick layer 2 to 4 times per day until the skin no longer absorbs the cream. Gently massage to help it penetrate.

• For non-infected wounds: clean the area thoroughly before application. Apply a thick layer extending well beyond the affected area and reapply as often as necessary so that a visible layer of cream remains on the surface.

Do not continue treatment for more than one week without medical advice. If there are signs of infection or no improvement after one week, consult your doctor.

Precautions

• Do not use as a sunscreen — BiafineAct does not contain UV filters.

• Not a cosmetic moisturizer — for damaged skin only.

• Do not apply to infected, bleeding, or oozing wounds.

• Avoid use if you are allergic to any ingredients listed.

• For extensive burns, wounds with blisters, or if uncertain about the nature of the injury, seek advice from a healthcare professional before applying.

Key Benefits

✅ Soothes pain and redness from minor burns and sunburns
✅ Promotes faster healing of superficial skin damage
✅ Moisturizes and protects damaged skin
✅ Suitable for children from 30 months, adults, and during pregnancy or breastfeeding

Made in France

Trusted by generations for its soothing and healing power, BiafineAct is a French pharmacy classic used by families and healthcare professionals alike.

Please read the following full disclosure before purchasing our using this product.

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Updated: May 20, 2025

1. NAME OF THE MEDICINAL PRODUCT

BIAFINEACT, emulsion for cutaneous application

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Trolamine ...................................................................................................................... 0.670 g
For 100 g of cutaneous emulsion.

Excipients with known effect: propylene glycol, potassium sorbate, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), Yerbatone fragrance.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Emulsion for cutaneous application.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

• Treatment of superficial and limited burns, including localized sunburns.

• Non-infected skin wounds.

4.2 Posology and method of administration

Route of administration: Cutaneous use.

• Superficial and limited burns, including localized sunburns:
  Apply a thick layer until the skin refuses further absorption. Gently massage to help penetration. Repeat 2 to 4 times daily.

• Non-infected skin wounds:
  After cleaning the wound, apply a thick layer, extending well beyond the affected area. Reapply as often as necessary to ensure a continuous excess of emulsion remains over the lesion.

4.3 Contraindications

• Hypersensitivity to the active substance or to any excipient listed in section 6.1.

• Bleeding wounds.

• Infected lesions.

4.4 Special warnings and precautions for use

Special warnings
In the case of superficial burns or non-infected skin wounds, treatment should be adapted according to the size and location of the lesion, the patient’s age and medical history, any associated injuries, and the underlying cause.

Precautions for use

• This medicine is not a sunscreen.

• Do not use as a skin care cream on healthy skin.

• Do not apply near the eyes.

• This product contains 38 mg of propylene glycol per 1.65 g dose and may cause skin irritation.

• Do not use on babies under 4 weeks old with open wounds or large areas of damaged skin (e.g., burns).

• Contains potassium sorbate, which may cause local skin reactions (e.g., eczema).

• Contains sodium methyl and sodium propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

• Contains a Yerbatone fragrance, which includes the following substances:
  3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, benzyl benzoate, citral, citronellol, d-limonene, eugenol, geraniol, hexyl cinnamic aldehyde, hydroxycitronellal, isoeugenol, and linalool. These substances may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

Pregnancy
No data are available in pregnant women. However, no effects are expected on pregnancy or the fetus.

Breastfeeding
No data are available in breastfeeding women. However, no effects are expected on the nursing mother or the breastfed infant.

No data exist regarding the excretion of trolamine or its metabolites in breast milk.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Adverse reactions are classified according to frequency as follows:

• Uncommon (≥1/1,000 to <1/100)

• Rare (≥1/10,000 to <1/1,000)

• Very rare (<1/10,000)

General disorders and administration site conditions:

• Uncommon: mild and transient pain or stinging after application.

• Rare: contact allergy.

• Very rare: contact eczema requiring immediate discontinuation of treatment.

Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after marketing authorization is important for continuous monitoring of the benefit-risk balance.
Healthcare professionals should report any suspected adverse reaction via the national reporting system:
Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) and the network of Regional Pharmacovigilance Centers — website: https://signalement.social-sante.gouv.fr.

4.9 Overdose

No cases of overdose have been reported.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic class: Skin protectant – ATC code: D03AX12 (Dermatology).

Trolamine, when combined with fatty acids such as stearic acid, acts as an emulsifier.
After cutaneous application, it develops occlusive and moisturizing properties, enhances macrophage recruitment at the wound site, promotes dermal healing, and supports granulation tissue formation.

5.2 Pharmacokinetic properties

The effects of this medicine are limited to the superficial layers of the epidermis, where it promotes hydration.
No systemic effects are expected.

5.3 Preclinical safety data

In vitro mutagenicity and chromosomal aberration tests with trolamine were negative.

Results of carcinogenicity studies in rodents were inconclusive. No human data are available.

Trolamine showed embryotoxic effects in a reproduction study in chickens. No data are available in humans.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethylene glycol stearate, stearic acid, cetyl palmitate, solid paraffin, liquid paraffin, perhydrosqualene, propylene glycol, avocado oil, trolamine and sodium alginate, potassium sorbate, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), Yerbatone fragrance*, purified water.

*Composition of Yerbatone fragrance: deturpenated orange essential oil, galbanum essential oil, deturpenated petitgrain essential oil, lemongrass essential oil, celestolide, para-tert-butyl cyclohexyl acetate, alpha-hexyl cinnamaldehyde, citral, limonene, phenylethyl alcohol, traseolide, hercolyn, phenylethyl acetate, methyl ionone, dipropylene glycol, isopropyl myristate, methyl dihydrojasmonate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not freeze.

6.5 Nature and contents of container

Aluminum tube of 139.5 g or 186 g, internally coated with an epoxy-phenolic varnish and closed with a high-density polypropylene cap.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and handling

Any unused product or waste material should be disposed of in accordance with local regulations.

7. MARKETING AUTHORIZATION HOLDER

KENVUE FRANCE
43 Rue Camille Desmoulins
92130 Issy-les-Moulineaux, France

8. MARKETING AUTHORIZATION NUMBER(S)

• 34009 378 320 9 0 – 1 varnished aluminum tube of 139.5 g

• 34009 378 317 8 9 – 1 varnished aluminum tube of 186 g

9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION

[To be completed later by the holder]

10. DATE OF REVISION OF THE TEXT

[To be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

Medicinal product not subject to medical prescription.