FOUNDATION

US over-the-counter (OTC) label

Brand or trade name

FOUNDATION

Manufacturer

OXYGEN DEVELOPMENT LLC

Label date

10 February 2023

Stated use in the United States

Purpose Sunscreen

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

• Medicinal Ingredient / Active Ingredient Octinoxate 5.0% w/w : Actif ou fonction insuffisamment identifiés : autorisation comme filtre UV dans l’Union européenne à vérifier.

Cosmetic analysis in the European Union

8 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. 50 names recognised out of 52.

Warning: 2 names out of 52 are not recognised (Medicinal Ingredient / Active Ingredient Octinoxate 5.0% w/w, Non-medicinal Ingredients / Inactive Ingredients Aqua): nothing below covers them.

Medicinal Ingredient / Active Ingredient Octinoxate 5.0% w/w, Non-medicinal Ingredients / Inactive Ingredients Aqua, Cyclopentasiloxane, Propanediol, Sodium PCA, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Boron Nitride, Dimethicone/Vinyl Dimethicone Crosspolymer, C12-15 Alkyl Ethylhexanoate, Magnesium Sulfate, Silica Silylate, Zinc Stearate, Phenoxyethanol, Mannitol, Bis-PEG/PPG-14/14 Dimethicone, Laureth-7, Amodimethicone, Lecithin, Tribehenin, Butyrospermum Parkii (Shea) Butter Extract, Sodium Starch Octenylsuccinate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Disteardimonium Hectorite, Glucosamine HCl, Trihydroxystearin, Dimethiconol, Triethoxycaprylylsilane, Pisum Sativum (Pea) Extract, Xanthan Gum, Bambusa Vulgaris Leaf/Stem Extract, Hydroxyethylcellulose, Tocopheryl Acetate, Ethylhexylglycerin, Propylene Carbonate, Sodium Gluconate, Pentylene Glycol, Lactic Acid, Citric Acid, Sodium Citrate, Dextrin, Retinol, Waltheria Indica Leaf Extract, Ferulic Acid, EDTA, Ceramide AP, Mica, Titanium Dioxide (CI 77891), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Iron Oxides (CI 77491, CI 77492, CI 77499), Iron Oxides (CI 77491, CI 77492, CI 77499)

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.
  • 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 PROPYLENE CARBONATEClassified 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 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 EDTAClassified 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.

• 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).
  • 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 RETINOLAnnex 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).

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

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), Washington State, California.

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 10 February 2023 (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