CompoAtlas

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.

Brand or trade name
CREAM
Manufacturer
OXYGEN DEVELOPMENT, LLC
Label date
10 February 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, Polysilicone-11, Mica, 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.

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

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, Polysilicone-11, Mica, 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.

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.

Selling elsewhere
CountryProhibitedProhibited in some casesSubject 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.

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 4Annexes IV, V and VI: only the colorants, preservatives and UV filters on these lists are allowed, under their conditions. Dashed underline.No specific rule 14In no annex: the ingredient remains subject to the general product safety obligation. This is not an opinion on its safety.Not recognised 0Name 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)
Titanium Dioxide 4.55%TITANIUM DIOXIDEAllowed 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 OXIDEUV 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
CyclopentasiloxaneCYCLOPENTASILOXANENo specific rule in the Cosmetics Regulationnone
IsododecaneISODODECANENo specific rule in the Cosmetics Regulationnone
Polysilicone-11POLYSILICONE-11No specific rule in the Cosmetics Regulationnone
MicaMICANo specific rule in the Cosmetics Regulationnone
PolymethylsilsesquioxanePOLYMETHYLSILSESQUIOXANENo specific rule in the Cosmetics Regulationnone
Hexyl LaurateHEXYL LAURATENo specific rule in the Cosmetics Regulationnone
PEG-10 DimethiconePEG-10 DIMETHICONENo specific rule in the Cosmetics Regulationnone
Polyglyceryl-4 IsostearatePOLYGLYCERYL-4 ISOSTEARATENo specific rule in the Cosmetics Regulationnone
Stearic AcidSTEARIC ACIDNo specific rule in the Cosmetics Regulationnone
Cetyl PEG/PPG-10/1 DimethiconeCETYL PEG/PPG-10/1 DIMETHICONENo specific rule in the Cosmetics Regulationnone
AluminaALUMINANo specific rule in the Cosmetics Regulationnone
TriethoxycaprylylsilaneTRIETHOXYCAPRYLYLSILANENo specific rule in the Cosmetics Regulationnone
Dipalmitoyl HydroxyprolineDIPALMITOYL HYDROXYPROLINENo specific rule in the Cosmetics Regulationnone
Diamond PowderDIAMOND POWDERNo specific rule in the Cosmetics Regulationnone
Iron OxidesCI 77491
Certainty medium: iron oxides group (CI 77491, CI 77492, CI 77499), individual pigments not established
Colorant allowed under conditions (Annex IV)none
Iron OxidesCI 77492
Certainty medium: iron oxides group (CI 77491, CI 77492, CI 77499), individual pigments not established
Colorant allowed under conditions (Annex IV)none
Iron OxidesCI 77499
Certainty medium: iron oxides group (CI 77491, CI 77492, CI 77499), individual pigments not established
Colorant allowed under conditions (Annex IV)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 2023. Photograph the packaging to check whether it has changed. Photograph the packaging

List recorded in 2023. Photograph the packaging to check whether it has changed.

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