CREAM
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
- CREAM
- Manufacturer
- OXYGEN DEVELOPMENT, LLC
- Label date
- 19 June 2023
Stated use in the United States
Purpose Sunscreen
Published active ingredients
Titanium Dioxide 4.55% Zinc Oxide 3.5%
Published inactive ingredients
Cyclopentasiloxane, Isododecane, Mica, Polysilicone-11, Polymethylsilsesquioxane, Hexyl Laurate, PEG-10 Dimethicone, Polyglyceryl-4 Isostearate, Stearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Alumina, Triethoxycaprylylsilane, Dipalmitoyl Hydroxyproline, Diamond Powder, Iron Oxides.
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.
Sunscreen filters and the European Union
- Titanium Dioxide 4.55% : Filtre UV autorisé sous les conditions de l’annexe VI du règlement (CE) 1223/2009.
- Zinc Oxide 3.5% : Filtre UV autorisé sous les conditions de l’annexe VI du règlement (CE) 1223/2009.
Cosmetic analysis in the European Union
5 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. 19 names recognised out of 19.
Titanium Dioxide 4.55%, Zinc Oxide 3.5%, Cyclopentasiloxane, Isododecane, Mica, Polysilicone-11, Polymethylsilsesquioxane, Hexyl Laurate, PEG-10 Dimethicone, Polyglyceryl-4 Isostearate, Stearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Alumina, Triethoxycaprylylsilane, Dipalmitoyl Hydroxyproline, Diamond Powder, Iron Oxides, Iron Oxides, Iron Oxides
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.
Environment
- Prohibition or serious classification CYCLOPENTASILOXANEECHA has included it in the Candidate List (substances of very high concern, REACH Regulation) because it is persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB).
- Worth watching ZINC OXIDEClassified 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).
No official text covers the recognised ingredients for: pregnancy and breastfeeding, babies and children, skin, eyes and allergies, 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 | - | - | Titanium Dioxide 4.55%, Zinc Oxide 3.5%, Iron Oxides |
| South Korea | - | - | Titanium Dioxide 4.55%, Zinc Oxide 3.5%, Cyclopentasiloxane |
| Australia | - | - | Titanium Dioxide 4.55%, Zinc Oxide 3.5% |
| ASEAN | - | - | Titanium Dioxide 4.55%, Zinc Oxide 3.5%, Iron Oxides |
| Taiwan | - | - | Titanium Dioxide 4.55%, Zinc Oxide 3.5%, Iron Oxides |
| Brazil | - | - | Titanium Dioxide 4.55%, Zinc Oxide 3.5% |
No prohibition or condition found in the recorded lists for: United States (federal), Washington State, California, Canada, Japan, China.
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) |
|---|---|---|---|
| Titanium Dioxide 4.55% | TITANIUM DIOXIDE | Allowed with restrictions (Annex III) UV filter allowed under conditions (Annex VI) Colorant allowed under conditions (Annex IV) Separate entry for the nano form (Annex VI) Annex III, entry 321: products: (a) face products in loose powder form (b) hair aerosol spray products (c) other products; maximum concentration: (a) 25%; (b) 1.4% for general consumers, and 1.1% for professional use. Annex VI, entry 27: maximum concentration: 25%* *: In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g (Maximum concentration in ready for use preparation) | none |
| Zinc Oxide 3.5% | ZINC OXIDE | UV filter allowed under conditions (Annex VI) Colorant allowed under conditions (Annex IV) Separate entry for the nano form (Annex VI) Annex VI, entry 30: maximum concentration: - 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25% | none |
| Cyclopentasiloxane | CYCLOPENTASILOXANE | No specific rule in the Cosmetics Regulation | none |
| Isododecane | ISODODECANE | No specific rule in the Cosmetics Regulation | none |
| Mica | MICA | No specific rule in the Cosmetics Regulation | none |
| Polysilicone-11 | POLYSILICONE-11 | No specific rule in the Cosmetics Regulation | none |
| Polymethylsilsesquioxane | POLYMETHYLSILSESQUIOXANE | No specific rule in the Cosmetics Regulation | none |
| Hexyl Laurate | HEXYL LAURATE | No specific rule in the Cosmetics Regulation | none |
| PEG-10 Dimethicone | PEG-10 DIMETHICONE | No specific rule in the Cosmetics Regulation | none |
| Polyglyceryl-4 Isostearate | POLYGLYCERYL-4 ISOSTEARATE | No specific rule in the Cosmetics Regulation | none |
| Stearic Acid | STEARIC ACID | No specific rule in the Cosmetics Regulation | none |
| Cetyl PEG/PPG-10/1 Dimethicone | CETYL PEG/PPG-10/1 DIMETHICONE | No specific rule in the Cosmetics Regulation | none |
| Alumina | ALUMINA | No specific rule in the Cosmetics Regulation | none |
| Triethoxycaprylylsilane | TRIETHOXYCAPRYLYLSILANE | No specific rule in the Cosmetics Regulation | none |
| Dipalmitoyl Hydroxyproline | DIPALMITOYL HYDROXYPROLINE | No specific rule in the Cosmetics Regulation | none |
| Diamond Powder | DIAMOND POWDER | No specific rule in the Cosmetics Regulation | none |
| Iron Oxides | CI 77491 Certainty medium: iron oxides group (CI 77491, CI 77492, CI 77499), individual pigments not established | Colorant allowed under conditions (Annex IV) | none |
| Iron Oxides | CI 77492 Certainty medium: iron oxides group (CI 77491, CI 77492, CI 77499), individual pigments not established | Colorant allowed under conditions (Annex IV) | none |
| Iron Oxides | CI 77499 Certainty medium: iron oxides group (CI 77491, CI 77492, CI 77499), individual pigments not established | Colorant allowed under conditions (Annex IV) | none |
List in the official revision dated (register: openFDA: US OTC product labels, analysed under European cosmetic rules).
List recorded in 2023. Photograph the packaging to check whether it has changed. Photograph the packaging