Ingredient
CI 16185
CI 16185 is flagged for pregnancy. The concern behind the strongest flag is absorbed into the body.
- Acid Red 14
- Amaranth
- Food Red 9
- E123
Verdict by profile
Truva checks every ingredient against six profiles. Jump to any of them for the full assessment.
- Strongest verdict
- Caution Advised
- Its verdict for pregnancy, the profile this one is worst in
- Profiles flagged
- 1 of 6
- Counting avoid, high risk and medium risk
- Irritancy
- 2 of 5
- Higher means more likely to sting or redden
CI 16185 and pregnancy
Caution Advised
- Absorbed into the body
CI 16185 (Amaranth) is a synthetic azo dye used to provide red coloring in cosmetic products. Azo dyes are a class of synthetic colorants created through chemical synthesis, some of which have raised historical safety concerns. This particular dye was banned from food use in the United States in 1976 following animal studies that suggested potential health concerns, though it remains approved for cosmetic use in both the US and EU with restrictions. While topical application results in much lower absorption than ingestion, and specific pregnancy studies on cosmetic use are lacking, some obstetricians recommend avoiding products with controversial synthetic dyes during pregnancy as a precautionary measure. The concern is not based on confirmed harm but rather on the ingredient's historical regulatory restrictions and the general principle of minimizing exposure to non-essential synthetic chemicals during pregnancy. The SCCS has evaluated this colorant and permits its use in cosmetics at restricted concentrations, indicating it can be used safely when properly formulated. However, given the limited pregnancy-specific data and the ingredient's controversial history, many healthcare providers suggest pregnant women may prefer products colored with alternative dyes that have clearer safety profiles during pregnancy.
CI 16185 and breastfeeding
Safe to Use
CI 16185 used topically in cosmetics has minimal systemic absorption and is unlikely to reach breast milk in significant amounts. The ingredient is applied to the skin's surface in products like lipsticks, blushes, and nail polishes where absorption is very limited. While specific breastfeeding studies are not available for this colorant, dermatologists generally consider cosmetic colorants used in typical products to pose minimal risk during breastfeeding due to their low absorption and localized use. The amounts that might be absorbed from cosmetic use are far lower than the oral exposures that led to food safety concerns. Most healthcare providers do not specifically restrict CI 16185 in cosmetics during breastfeeding, though as with any cosmetic product, it's advisable to avoid applying directly to the breast or nipple area. Women who prefer to minimize exposure to synthetic dyes may choose alternatives, but the risk from normal cosmetic use during breastfeeding is considered low.
CI 16185 and postpartum
Safe to Use
- Common allergen
CI 16185 poses no specific concerns for postpartum women who are not breastfeeding beyond the general potential for allergic reactions or irritation that exists for all users. The ingredient has no hormonal effects and does not interfere with postpartum recovery. As with any azo dye, there is a possibility of contact dermatitis in sensitive individuals. Postpartum skin may be more sensitive in some women, so patch-testing products with this ingredient may be advisable if you have a history of reactions to synthetic dyes.
CI 16185 and trying to conceive
Safe to Use
CI 16185 has no known effects on fertility or reproductive function when used topically in cosmetics. The minimal absorption from cosmetic use means systemic exposure is very low, and there are no mechanisms by which this colorant would affect conception. Women trying to conceive may choose to avoid products with this ingredient if they prefer to minimize exposure to synthetic dyes with controversial safety histories, though the risk from cosmetic use is considered low. There is no evidence that topical use of CI 16185 in cosmetics interferes with ovulation, fertilization, or implantation.
CI 16185 and PCOS
Safe to Use
CI 16185 has no hormonal activity and does not affect androgen levels, insulin sensitivity, or other metabolic factors relevant to PCOS. It functions solely as a colorant without biological activity beyond its potential for causing allergic reactions in sensitive individuals. For women with PCOS, this ingredient poses no specific endocrine or metabolic concerns. It does not influence sebum production, acne development, or hormonal balance. The only consideration would be individual sensitivity to synthetic dyes, which is not specific to PCOS. Dermatologists treating PCOS-related skin conditions have no restrictions on cosmetic colorants like CI 16185. The ingredient is purely cosmetic in function and does not interact with PCOS management or treatments.
CI 16185 and general use
Safe to Use
- Common allergen
- Irritant
CI 16185 is approved for use in cosmetics in both the EU and US, though with concentration restrictions in the EU. It provides bright red coloring in various cosmetic products including lipsticks, blushes, and nail products. According to the SCCS, this colorant can be used safely in cosmetics when formulated at appropriate concentrations (maximum 0.5% in rinse-off products, 0.2% in leave-on products). The main concerns are potential for allergic reactions and irritation in sensitive individuals, which is common with azo dyes. Some people may experience contact dermatitis from products containing this ingredient. While the FDA banned it from food use in 1976, cosmetic use results in much lower exposure and is considered acceptably safe under current regulations. For the general public, CI 16185 is considered low-risk when used in properly formulated cosmetics at approved concentrations. Individuals with sensitive skin or known allergies to synthetic dyes may want to avoid this ingredient or patch-test products before use. Those who prefer to avoid controversial synthetic colorants can choose products with natural or mineral-based alternatives.
Everything else flagged for the same profiles
Related ingredients
Ingredients suggested in place of CI 16185, each one with its own page here.
Ingredients that raise the same concerns.
Where this came from
Truva summarises published guidance from bodies including ACOG, the FDA, the EU SCCS and the Cosmetic Ingredient Review. It has no access to your medical history and it is not a substitute for your doctor, dermatologist or midwife. These assessments have not been reviewed by a clinician, and nothing here is a diagnosis or a prescription. If you are pregnant, breastfeeding or being treated for PCOS, take the ingredient list to the person looking after you.
Assessment last pulled from the ingredient database on .
One ingredient is the easy case.
A label has thirty of them. Truva reads the whole list at once and answers for the profile you set: pregnancy, breastfeeding, postpartum, trying to conceive, PCOS, or general use.
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