DR527
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.
openFDA: US OTC product labels, analysed under European cosmetic rules, retrieved 28 October 2026.
- Brand or trade name
- DR527
- Manufacturer
- PHYSICIANS CARE ALLIANCE, LLC DBA PCA SKIN
- Label date
- 6 October 2021
Stated use in the United States
Purpose Skin protectant (ointment) Uses Helps relieve, prevent and temporarily protect chafed, chapped or cracked skin. Use as a lubricant to prevent further irritation.
Published active ingredients
Petrolatum (60%)
Published inactive ingredients
Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Panthenol, Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silybum Marianum Fruit Extract, Stearyl Glycyrrhetinate, Tocopherol, Tocopheryl Acetate.
openFDA: US OTC product labels, analysed under European cosmetic rules, retrieved 28 October 2026.
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, except for the cases the Regulation provides: Petrolatum 60%; its rule says which. 1 ingredient 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 14.
Petrolatum 60%, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Panthenol, Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silybum Marianum Fruit Extract, Stearyl Glycyrrhetinate, Tocopherol, Tocopheryl Acetate
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.
Skin, eyes and allergies
- 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.
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.
| Country | Prohibited | Prohibited in some cases | Subject to conditions |
|---|---|---|---|
| United Kingdom | Petrolatum 60% | - | Phenoxyethanol |
| Japan | - | - | Phenoxyethanol |
| South Korea | - | - | Phenoxyethanol, Tocopherol |
| China | Petrolatum 60% | - | - |
| ASEAN | - | Petrolatum 60% | Phenoxyethanol |
| Taiwan | - | - | Phenoxyethanol |
| Brazil | Petrolatum 60% | - | Phenoxyethanol |
No prohibition or condition found in the recorded lists for: United States (federal), Washington State, California, Canada, 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”.
| On the label | Glossary name | Rule in the European Union | Classified hazard (cancer, DNA, reproduction) |
|---|---|---|---|
| Petrolatum 60% | PETROLATUM | Prohibited unless refining is demonstrated (Annex II) | none |
| Butyrospermum Parkii (Shea) Butter | BUTYROSPERMUM PARKII BUTTER Certainty high: name recognised, the brackets add a detail | No specific rule in the Cosmetics Regulation | none |
| Caprylic/Capric Triglyceride | CAPRYLIC/CAPRIC TRIGLYCERIDE | No specific rule in the Cosmetics Regulation | none |
| Carthamus Tinctorius (Safflower) Seed Oil | CARTHAMUS TINCTORIUS SEED OIL Certainty high: name recognised, the brackets add a detail | No specific rule in the Cosmetics Regulation | none |
| Helianthus Annuus (Sunflower) Extract | HELIANTHUS ANNUUS EXTRACT Certainty high: name recognised, the brackets add a detail | No specific rule in the Cosmetics Regulation | none |
| Helianthus Annuus (Sunflower) Seed Wax | HELIANTHUS ANNUUS SEED WAX Certainty high: name recognised, the brackets add a detail | No specific rule in the Cosmetics Regulation | none |
| Oryza Sativa (Rice) Bran Extract | ORYZA SATIVA BRAN EXTRACT Certainty high: name recognised, the brackets add a detail | No specific rule in the Cosmetics Regulation | none |
| Panthenol | PANTHENOL | No specific rule in the Cosmetics Regulation | none |
| Phenoxyethanol | PHENOXYETHANOL | Preservative allowed under conditions (Annex V) Annex V, entry 29: maximum concentration: 1.0% | none |
| Rosmarinus Officinalis (Rosemary) Leaf Extract | ROSMARINUS OFFICINALIS LEAF EXTRACT Certainty high: name recognised, the brackets add a detail | No specific rule in the Cosmetics Regulation | none |
| Silybum Marianum Fruit Extract | SILYBUM MARIANUM FRUIT EXTRACT | No specific rule in the Cosmetics Regulation | none |
| Stearyl Glycyrrhetinate | STEARYL GLYCYRRHETINATE | No specific rule in the Cosmetics Regulation | none |
| Tocopherol | TOCOPHEROL | No specific rule in the Cosmetics Regulation | none |
| Tocopheryl Acetate | TOCOPHERYL ACETATE | No specific rule in the Cosmetics Regulation | none |
List in the official revision dated (register: openFDA: US OTC product labels, analysed under European cosmetic rules).
List recorded in 2021. Photograph the packaging to check whether it has changed. Photograph the packaging