- What is a Safe Sunscreen? |
- FDA Approved Sunscreen Ingredients |
- Sunscreen Ingredients, Approved in EU, AU or Japan |
- Possible Harmful Sunscreen Effects |
- Ingredients That Dry Up the Skin |
- Ingredients Causing Irritant or Allergic Dermatitis |
- Ingredients Causing Photosensitivity |
- Ingredients Causing Acne |
- Ingredients Causing Skin Ageing |
- Ingredients Causing Cancer |
- Ingredients Causing Other Symptoms |
- Nanoparticles in Sunscreens |
- Cosmetic Ingredients, Prohibited or Restricted by FDA |
- Ask a Doctor
What is a Safe Sunscreen?
If you want to be safe from the sun, avoid the sun. The next step is wearing sun-protecting clothes, together with applying sunscreen. There is no sunscreen that is 100% safe. Also, people often do not apply sunscreen generously or often enough (re-applying every 2 hours is recommended).
Safe sunscreen product should:
- Have sun protective factor (SPF) at least 15
- Not contain any harmful ingredients
- Terms, like organic or natural sunscreen may be highly misleading. Any producer can put some herbs in the sunscreen and claim it is organic. Even certified organic sunscreens are not safe just from being organic – allergies to organic compounds are possible.
- Sunscreens used today are also never “all day”or completely “waterproof”, as some producers claim.
FDA Approved Sunscreen Ingredients
US Federal Drugs Administration (FDA) has approved the following 17 active sunscreen ingredients for use in over-the-counter sunscreen products:
- Aminobenzoic acid (PABA) in concentration up to 15 percent (in grams of the total mass of a sunscreen product)
- Avobenzone up to 3 percent
- Cinoxate up to 3 percent
- Dioxybenzone up to 3 percent
- Ecamsule (terephthalylidene dicamphor sulfonic acid) up to 10 percent, approved by FDA on July 24, 2006, is commercially available as Anthelios SX in US, and Mexoryl SX in EU and AU
- Homosalate up to 15 percent
- Menthyl anthranilate up to 5 percent
- Octocrylene up to 10 percent
- Octyl methoxycinnamate up to 7.5 percent
- Octyl salicylate up to 5 percent
- Oxybenzone up to 6 percent
- Padimate O up to 8 percent
- Phenylbenzimidazole sulfonic acid up to 4 percent
- Sulisobenzone up to 10 percent
- Titanium dioxide up to 25 percent
- Trolamine salicylate up to 12 percent
- Zinc oxide up to 25 percent.
Note that only active sunscreen ingredients that protect skin against UV-rays are listed. Sunscreens sold in USA pharmacies are considered as over-the-counter (OTC) drugs, so they may contain only FDA approved active ingredients listed above.
Beside active ingredients, there are several other sunscreens ingredients in sunscreens, including water, salt, herbal extracts, oils or alcohols that hold the active ingredients, preservatives, fragrances, and so on, that are considered as cosmetic ingredients, and are therefore not a subject of FDA approval authority.
Sunscreen Ingredients, Approved in EU, AU or Japan
The following sunscreen ingredients are not approved by FDA, but are approved in EU, AU (by therapeutic goods administration (TGA)) or Japan (1):
- 1-(3,4-dimetoxyphenyl)-4,4-dimethyl-1,3-penta nediene (EU)
- 3-methylbenzylidene camphor (AU)
- 4-(2-beta-glucopyranosiloxy) propoxy-2-hydroxybenzophenone (EU)
- 4-methylbenzylidene camphor (AU, Japan)
- Benzocaine (EU)
- Benzophenone-1 and -2,-5,-6,-9 (EU)
- Benzylidene camphor sulfonic acid (AU, Japan)
- Camphor benzalkonium methosulphate (AU, Japan)
- Diethylamino hydroxybenzoylhexyl benzoate (AU)
- Diethylexyl butamido triazone (AU)
- Diisopropyl methyl cinnamate (EU)
- Disodium phenyl dibenzimidazole tertrasulfonate (AU, Japan)
- Ethylexyl dimethoxybenzylidene dioxoimidazolidene propionate (EU)
- Ethylexyl triazone (EU, AU, Japan)
- Ferulic acid (EU)
- Glycerylethylexylhexanoate dimethoxicinnamate (EU)
- Glyceryl PABA (EU)
- Isoamyl p-methoxicinnamate (AU, Japan)
- Isopentyl trimethoxicinnamate trisiloxane (EU)
- Isopropyl methoxicinnamate (EU)
- Methylene bis-benzotriazolyl tetramethylbutylphenol (AU, Japan)
- PEG-25 PABA (AU, Japan)
- Pentyl dimethyl PABA (EU)
- Polyacrylamidomethylbenzylidene camphor (AU)
- Polysilicone-15 (AU)
- Tinosarb S (AU)
Possible Harmful Sunscreen Effects
Some sunscreen ingredients may cause:
- Dryness of the skin
- Irritant or allergic dermatitis
- Skin ageing
- Other symptoms (after inhalation or ingestion of a sunscreen)
Ingredients That Dry Up the Skin
Sunscreen ingredients that dry up the skin:
- Alcohol, Isopropyl (SD40) dries up the skin, promotes brown spots and premature skin aging (1).
Ingredients Causing Irritant or Allergic Dermatitis
Substances that may irritate the skin and mucosa or cause allergic reactions (eczema) (1):
- Parabens are used as preservatives. They may cause skin rashes, redness, and pain, or, after inhalation, irritation of the eyes and the mucosa of the nose and throat.
- Methylisothiazolinone and methylchloroisothiazolinone
- Bronopol (2-bromo-2-nitropropane-1,3-diol)
- Propylene/butylene glycol is derived from petroleum. It is used to extract substances from herbs.
- Quaternium-7, -15, -31, -60, etc
- Stearalkonium chloride
Ingredients Causing Photosensitivity
Some sunscreen ingredients, after exposure to the sun, may yield substances that may cause photosensitivity – a strong skin reaction, resembling sunburn (4):
- PABA (para-aminobenzoic acid, rarely found in sunscreens today)
- Fragrances: musk, 6-methylcoumarin
Ingredients Causing Acne
The following substances may cause acne:
- Mineral oil and other petroleum derivatives, like liquidum paraffinum (posh mineral oil), paraffin oil, paraffin wax, and petrolatum, clog pores, thus promoting acne (1).
Ingredients Causing Skin Ageing
Skin ageing is mainly caused by UVA rays. Prolonged, repeated exposure to the sun, when using any sunscreen product without sufficient UVA filtering, may result in skin ageing. The following sunscreen ingredients may also cause skin ageing (1):
- Mineral oil and related products
Ingredients Causing Cancer
The following substances were found to cause cancer (1):
- TEA, DEA, MEA (tri-, di- and mono- ethaloamines) can cause liver and kidney cancer. They are also corrosive to the eyes, and cause allergic reactions.
- Formaldehyde is carcinogenic. It is strongly irritant to the eyes and throat and causes irritant and allergic dermatitis.
- Diazolidinyl and imidazolidinyl urea (Germall 115) may release formaldehid, so it is irritant and carcinogenic.
- Most of FD&C color pigments are carcinogenic (according to animal studies). They also contain heavy metals that may cause skin sensitivity.
- The following nitrosating agents were proven to cause cancer in laboratory animals:
- Cocoyl sarcosine
- Hydrolysed animal protein
- Lauryl sarcosine
- Quaternium-7, 15, 31, 60, etc
- Sodium lauryl sulfate (SLS), ammonium lauryl sulfate (ALS), sodium laureth sulfate (SLES), ammonium laureth sulfate (ALES)
- Sodium methyl cocoyl taurate
- Lanolin is obtained from the wool, so it is often contaminated with chemicals used on sheep (pesticides).
- Mineral oil can be contaminated with PAHs (polycyclic aromatic hydrocarbons) that cause cancer.
- Talc, routinely used in genital area, increases the risk of ovarian cancer.
Ingredients Causing Other Symptoms
Symptoms of a damage of internal organs may be caused by (1):
- Fragrances (substances that give the smell to the cosmetic product). Their exact composition is usually not revealed on labels, but one or more of several thousands substances may be included. They may cause headache, dizziness, allergic rashes, skin discoloration, violent coughing and vomiting, depression, hyperactivity and irritability.
- Propylene/butylene glycol is derived from petroleum and is used to extract substances from herbs. It is highly toxic and may cause eye, nose and throat irritation (after inhalation), neurological and blood disorders and pulmonary edema.
Nanoparticles in Sunscreens
Nanoparticles are particles 1-100 nanometers in size (1 nanometer is one millionth of millimeter). They usually represent particles of zinc oxide and titanium dioxide that were broken down to prevent opacity and thickness of sunscreen. According to Environmental Working Group, nanoparticles do not represent damage to the human body if used on intact skin (2). Australian Therapeutic Goods Administration claims the same (3).
Cosmetic Ingredients, Prohibited or Restricted by FDA
USA Federal Drug Administration (FDA) prohibits or restricts use of the following ingredients in cosmetics (they rarely appear in sunscreens, though):
- Prohibited ingredients:
- Bithionol – may cause photosensitization.
- Chlorofluorocarbon propellants.
- Chloroform – was determined as cancerogenous in animal tests. Residual amounts from its use as a processing solvent are allowed.
- Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide) – may cause photosensitization.
- Methylene chloride – determined as carcinogenic in animal tests.
- Vinyl chloride – prohibited in aerosol products, bacause it is carcinogenic.
- Zirconium-containing complexes– prohibited in aerosol products because of their lung toxicity (granuloma formation).
- Some cattle materials are prohibited to protect against bovine spongiform encephalopathy (BSE, ‘mad cow disease’). Allowed cattle materials are tallow, hides, milk and their derivates [21 CFR 700.27, as amended].
- Restricted ingredients:
- Hexachlorophene (HCP) may penetrate the skin, so its concentration in the product may not exceed 0.1 percent and may not be used in lipsticks.
- Mercury compounds may be absorbed through the skin and cause allergic reactions or chronic neurological symptoms. Their concentration may not exceed 65 parts per million in eye area cosmetics or 1 part per million in other cosmetics.
- If a sunscreens is used in cosmetics only “to protect the product color”, this has to be clearly denoted on the product label, otherwise a product labeled as “contains sunscreen” may be considered as a drug by FDA regulation.