ASTONEAGRAN

US over-the-counter (OTC) label

Brand or trade name

ASTONEAGRAN

Manufacturer

ASTONEA LABS PRIVATE LIMITED

Label date

25 June 2024

Stated use in the United States

Purpose Skin Protectant

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

1 ingredient prohibited in cosmetics in the European Union: Cholecalciferol. A product that contains it should no longer be sold in the Union. 1 ingredient prohibited, except for the cases the Regulation provides: Petrolatum; its rule says which. 6 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. 18 names recognised out of 20.

Warning: 2 names out of 20 are not recognised (Gel, Zea Mays Corn Oil): nothing below covers them.

• Pregnancy and breastfeeding : Prohibition or serious classification CHOLECALCIFEROL
• Babies and children : Worth watching ZINC CHLORIDE

Aluminium Hydroxide, Gel, Calcium Carbonate, Cholecalciferol, Citric Acid, DMDM Hydantoin, Ethylhexylglycerin, Lanolin, Lanolin Alcohol, Magnesium Hydroxide, Petrolatum, Phenoxyethanol, Propylene Glycol, Purified Water, Retinyl Palmitate, Sodium Chloride, Sodium Laureth Sulfate, Stearyl Alcohol, Zea Mays Corn Oil, Zinc Chloride

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.

• Pregnancy and breastfeeding

  • Prohibition or serious classification CHOLECALCIFEROLAn EU act identifies it as an endocrine disruptor for human health: Regulation (EU) 2019/637 (approval, biocidal products).

• Babies and children

  • Worth watching ZINC CHLORIDEAnnex III, entry 24, sets a condition for children, for these products only: (b) Toothpaste intended for children between 6 months and 1 year of age. “(b) Toothpaste intended for children between 6 months and 1 year of age”

• Skin, eyes and allergies

  • For information CITRIC ACIDClassified under the CLP Regulation: eye irritation, category 2 (Eye Irrit. 2). This classification describes the pure substance; in a finished product it is far more diluted.
  • For information ETHYLHEXYLGLYCERINClassified under the CLP Regulation: serious eye damage, category 1 (Eye Dam. 1). This classification describes the pure substance; in a finished product it is far more diluted.
  • For information PHENOXYETHANOLClassified under the CLP Regulation: serious eye damage, category 1 (Eye Dam. 1). This classification describes the pure substance; in a finished product it is far more diluted.
  • For information ZINC CHLORIDEClassified under the CLP Regulation: skin corrosion, category 1B (Skin Corr. 1B). This classification describes the pure substance; in a finished product it is far more diluted.

• Environment

  • Worth watching ZINC CHLORIDEClassified under the CLP Regulation: hazardous to the aquatic environment, short term, category 1 (Aquatic Acute 1); hazardous to the aquatic environment, long term, category 1 (Aquatic Chronic 1).
  • For information ETHYLHEXYLGLYCERINClassified under the CLP Regulation: hazardous to the aquatic environment, long term, category 3 (Aquatic Chronic 3).

• Read on the label

  • Worth watching RETINYL PALMITATEAnnex III, entry 376, requires this to be printed on the pack: “For any cosmetic product containing Retinol, Retinyl Acetate or Retinyl Palmitate the following, labelling is obligatory: ‘Contains Vitamin A. Consider your daily intake before use’.”. Regulation (EU) 2024/996 gives the reason: to inform people already exposed to vitamin A from food and food supplements that a cosmetic may add to an excess (recital 3).

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.

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

Ingredient by ingredient

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

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”.

All US nonprescription labels

List in the official revision dated 25 June 2024 (register: openFDA: US OTC product labels, analysed under European cosmetic rules).

List recorded in 2024. Photograph the packaging to check whether it has changed. Photograph the packaging