CompoAtlas

BIOREPAIR SENSITIVE TEETH

US over-the-counter (OTC) label

Aux États-Unis, ces produits sont vendus comme médicaments en vente libre (OTC) : solaires, antitranspirants, antipelliculaires, dentifrices anticaries, produits contre l'acné ou protecteurs cutanés. L'étiquette distingue les ingrédients actifs et inactifs. Dans l'Union européenne, un produit à finalité cosmétique doit respecter le règlement (CE) n° 1223/2009. Un filtre ou un actif admis aux États-Unis peut ne pas être autorisé pour cet usage dans l'Union. La qualification dépend de la finalité : un désinfectant pour les mains peut relever des biocides et un traitement de l'acné des médicaments. Cette analyse applique les règles cosmétiques aux ingrédients, sans établir la conformité du produit fini. La formule vendue en Europe sous le même nom peut être différente.

Brand or trade name
BIOREPAIR SENSITIVE TEETH
Manufacturer
COSWELL SPA
Label date
13 June 2017

Stated use in the United States

Biorepair Plus Sensitive Teeth creates a natural barrier against hypersensitivity for a quick relief. Biorepair Plus Sensitive Teeth is the toothpaste that contains microRepair, active biomimetic hydroxyapatite microparticles similar in composition to the teeth ones that are able to penetrate into micro-breaks, repair damaged enamel and occlude dentinal tubules.

Published active ingredients

Contains: Dicalcium Phosphate Dihydrate (0.6289 fl. oz.)

Published inactive ingredients

Ingredients: Aqua, Glycerin, Sorbitol, Cellulose Gum, PEG-32, Silica, Sodium Myristoyl Sarcosinate, Sodium Methyl Cocyl Taurate, Aroma, Citric Acid, Sodium Saccharin, Benzyl Alcohol, Phenoxtethanol, Sodium Benzoate

Label in the official openFDA API. This is the label date; the formula may have changed. Compare with the packaging.

Cosmetic analysis in the European Union

3 ingredients allowed under conditions (maximum concentration, product types): some active ingredient concentrations are printed; the other conditions and the product's classification in the European Union remain to be checked. 14 names recognised out of 15.

Warning: 1 name out of 15 is not recognised (Contains: Dicalcium Phosphate Dihydrate (0.6289 fl. oz.)): nothing below covers it.

Spelling corrected, check it on the packaging: “Sodium Methyl Cocyl Taurate” read as SODIUM METHYL COCOYL TAURATE; “Phenoxtethanol” read as PHENOXYETHANOL.

Contains: Dicalcium Phosphate Dihydrate (0.6289 fl. oz.), Aqua, Glycerin, Sorbitol, Cellulose Gum, PEG-32, Silica, Sodium Myristoyl Sarcosinate, Sodium Methyl Cocyl Taurate spelling corrected, Aroma, Citric Acid, Sodium Saccharin, Benzyl Alcohol, Phenoxtethanol spelling corrected, Sodium Benzoate

Who it concerns

For each group, the ingredients of the list that an official classification or rule mentions. Open an ingredient's page to read what the text says. A group with no name does not mean the ingredients were judged to have no effect for it.

Prohibition or serious classificationThe text prohibits the substance for this use, or ranks it among the most serious hazards (known or presumed carcinogenic, mutagenic or reprotoxic, identified endocrine disruptor).Worth watchingThe text sets a condition or flags a hazard worth knowing: allergen, suspected effect, condition for children, hazard to the aquatic environment.For informationOfficial information with no condition on a finished product: warning to read, irritation of the pure substance.

No official text covers the recognised ingredients for: pregnancy and breastfeeding, babies and children, environment, read on the label.

For a question about your own situation (pregnancy, child, allergy), show this list to your doctor, midwife or pharmacist: we cannot say whether this product suits you.

Selling elsewhere

Ingredients of this list that are prohibited, prohibited in some cases or subject to conditions in the other countries whose rules we record (nothing changes for sale in France). Absence is not approval: several countries only allow the preservatives, UV filters and colorants on their lists, and the function of an ingredient in the product is not known. What is covered for each country.

Selling elsewhere
CountryProhibitedProhibited in some casesSubject to conditions
United Kingdom--Benzyl Alcohol, Phenoxtethanol, Sodium Benzoate
Canada--Glycerin, Citric Acid
Japan--Phenoxtethanol
South Korea--Benzyl Alcohol, Phenoxtethanol, Sodium Benzoate
ASEAN--Benzyl Alcohol, Phenoxtethanol, Sodium Benzoate
Taiwan--Benzyl Alcohol, Phenoxtethanol, Sodium Benzoate
Brazil--Benzyl Alcohol, Phenoxtethanol, Sodium Benzoate

No prohibition or condition found in the recorded lists for: United States (federal), Washington State, California, China, Australia.

Ingredient by ingredient

The line under each name gives its rule in the European Union (legend below). Click a name for its page.

Prohibited 0Annex II of Regulation (EC) No 1223/2009: a cosmetic product may not contain this substance. Thick underline.Allowed with restrictions 1Annex III: allowed up to a maximum concentration, in certain product types, sometimes with a warning to print. A restriction does not mean that the product is non-compliant: some active concentrations are printed, the other conditions remain to be checked. Double underline.Allowed on a list, under conditions 2Annexes IV, V and VI: only the colorants, preservatives and UV filters on these lists are allowed, under their conditions. Dashed underline.No specific rule 11In no annex: the ingredient remains subject to the general product safety obligation. This is not an opinion on its safety.Not recognised 1Name absent from the EU glossary (typo, trade name, other language): it is not analysed. Dotted underline.

Hover over or tap a badge for its meaning.

Classified hazard (cancer, DNA, reproduction): Carcinogenic, mutagenic or toxic for reproduction under the CLPEU regulation that classifies chemicals by their hazards (EC No 1272/2008). Regulation, or identified endocrine disruptor. Irritation, allergy and environment: see “Who it concerns”.

Ingredient analysis
On the labelGlossary nameRule in the European UnionClassified hazard (cancer, DNA, reproduction)
Contains: Dicalcium Phosphate Dihydrate (0.6289 fl. oz.)not recognisedName not recognised in the European glossaryunknown
AquaAQUANo specific rule in the Cosmetics Regulationnone
GlycerinGLYCERINNo specific rule in the Cosmetics Regulationnone
SorbitolSORBITOLNo specific rule in the Cosmetics Regulationnone
Cellulose GumCELLULOSE GUMNo specific rule in the Cosmetics Regulationnone
PEG-32PEG-32No specific rule in the Cosmetics Regulationnone
SilicaSILICANo specific rule in the Cosmetics Regulationnone
Sodium Myristoyl SarcosinateSODIUM MYRISTOYL SARCOSINATENo specific rule in the Cosmetics Regulationnone
Sodium Methyl Cocyl Taurate spelling correctedSODIUM METHYL COCOYL TAURATE
Certainty medium: one letter away from a glossary name (likely typo)
No specific rule in the Cosmetics Regulationnone
AromaAROMANo specific rule in the Cosmetics Regulationnone
Citric AcidCITRIC ACIDEntry for a mixture with the same CAS number (Annex V)none
Sodium SaccharinSODIUM SACCHARINNo specific rule in the Cosmetics Regulationnone
Benzyl AlcoholBENZYL ALCOHOLAllowed with restrictions (Annex III)
Preservative allowed under conditions (Annex V)
Annex III, entry 45: products: (a) Solvent (b) Fragrance/ aromatic compositions/ their raw materials
Annex V, entry 34: maximum concentration: 1.0%
none
Phenoxtethanol spelling correctedPHENOXYETHANOL
Certainty medium: one letter away from a glossary name (likely typo)
Preservative allowed under conditions (Annex V)
Annex V, entry 29: maximum concentration: 1.0%
none
Sodium BenzoateSODIUM BENZOATEPreservative allowed under conditions (Annex V)
Annex V, entry 1: products: a) Rinse-off products, except oral care products b) Oral care products c) Leave-on products; maximum concentration: a) 2.5% (acid) b) 1.7% (acid) c) 0.5% (acid)
none

All US nonprescription labels

List in the official revision dated (register: openFDA: US OTC product labels, analysed under European cosmetic rules).

List recorded in 2017. Photograph the packaging to check whether it has changed. Photograph the packaging

List recorded in 2017. Photograph the packaging to check whether it has changed.

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