CAS Number: 1314-13-2
It is used topically as an astringent and skin protector, very often together with small amounts of Ferric Oxide to form Calamine (see specific info). It is a product compatible with breastfeeding according to WHO Essential Medicine’s List - 2002.It is also used in dental hygiene products and cosmetics. Widely used for skin protection of the diaper area in infants. Because of the small dose used and poor absorption into plasma of most topical dermatological preparations, excretion into breastmilk in significant amount appears to be unlikely. Do not apply on the breast to prevent infant ingestion; otherwise, wash it off thoroughly with water before the next breast feed.
Based on the current available safety data, octocrylene used as a UV filter in cosmetic products at a concentration of 10% can be considered as safe. There was no evidence of any endocrine disruption potential from experimental studies which demonstrated no adverse effects on reproductive (e.g. oestrus cycle, epididymal and testicular sperm parameters) and developmental parameters. Effects on thyroid reported in repeated toxicity studies conducted in rats at very high doses are species?specific and not relevant considering the doses at which octocrylene is used in human.
Four studies on the transdermal absorption of octocrylene are available in the scientific literature, and an additional study is available in ECHA summaries of safety data. Dermal absorption studies of octocrylene showed that most octocrylene concentrations are found in the stratum corneum and that very few quantities are found in the epidermis (0.4%) and in the receptor fluid (<0.05%). In vivo, a very recent study in human volunteers showed systemic exposure to octocrylene with maximal concentrations ranging from 2.9 to 7.8 ng/mL under indoor maximal use conditions. Octocrylene has been found at very low amounts in human milk, and some metabolites of octocrylene were primarily detected in urine of volunteers using sunscreen products.
No systemic effects were reported after dermal exposure to octocrylene in rabbits at very high dose (534 mg/kg bw/day) compared with those used in cosmetic products. After oral exposure, effects on liver and thyroid were reported in a study conducted in rats at high doses (340 and 1085 mg/kg bw/day in males). These effects were investigated in an additional mechanistic study which showed that effects on thyroid were indirect and due to hepatic enzyme induction potential of octocrylene in rats at very high oral doses.
Based on available animal data, octocrylene does not induce developmental or teratogenic effects. In an extended one?generation reproductive toxicity study, only rats treated with the highest dose of octocrylene via oral route showed a decrease in the number of implantation sites and consequently a low number of pups. This very high dose of 550 mg/kg bw/day cannot be considered to be relevant to the dermal use of octocrylene as a cosmetic ingredient. Moreover, no other effects on male and female fertility and reproductive parameters such as oestrus cycle, epididymal and testicular sperm parameters were observed in all groups tested. Regarding pups, no effects on sexual and neurodevelopmental parameters were observed.Note: Study and data for tropical use only
It is always a good idea to keep your healthcare provider or doctor informed about your drug usage during pregnancy and breastfeeding but if you have not informed your doctor about Walgreens Zinc Spf 50 | Octocrylene, Zinc Oxide Lotion and have used it then do not panic as Walgreens Zinc Spf 50 | Octocrylene, Zinc Oxide Lotion is mostly safe in breastfeeding and should not cause any harm to your baby.
Usage of Walgreens Zinc Spf 50 | Octocrylene, Zinc Oxide Lotion is safe for nursing mothers and baby, No worries.
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