Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick while Breastfeeding
Most health expert recommend six month of exclusive breastfeeding but statics suggest that numbers are not good, almost 95% mothers start breastfeeding but this number drops to 40% in first three month and further it drops to 15% till fifth month. Sometime its due to need of medication usage. Because of these statics its important to provide good information on safety of drugs in breastfeeding so that it can be improved when possible. In this FAQ sheet we will discuss about exposure to Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick while breastfeeding. We will also discuss about common side effects and warnings associated with Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick.

What is the use of Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick ?

Sunscreen

Is using Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick safe or dangerous while breastfeeding?

Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick high risk while breastfeeding
There are total 3 active ingredients in Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick which makes it a complicated task to assess the effect of Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick on breastfeeding. Here on drlact after analyzing all 3 ingredients we have reached on conclusion that Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick is unsafe in breastfeeding. Below is our summarized analysis of Octinoxate, Octisalate, Octocrylene.

Octinoxate and Breastfeeding

Unsafe

Octinoxate (Octylmethoxycinnamate) has been detected in human urine, blood and breast milk and is known for moderate risk of skin allergy. Some studies suggest that Octinoxate has estrogen like effects however less than 1% skin penetration has been found in human laboratory studies. As not much study has been done on effects of Octinoxate during breast feeding its recommended to use safe alternatives.

Octyl Methoxycinnamate (OMC) is a frequently used UV-filter in sunscreens and other cosmetics. Octinoxate can be systemically absorbed after skin application, being found in the deeper layers of the stratum corneum as well as urine, plasma, and breast milk. The mean maximum plasma concentration detected after application of 2mg/cm2 sunscreen was 7ng/mL in women and 16ng/mL in men. FDA study found blood levels 13 times above cutoff for systemic exposure.

Several studies indicated that OMC acts as an endocrine disruptor due to the ability to interfere with endocrine system at different levels. In humans OMC exposure has minor, but statistically significant effects on the levels of testosterone and estradiol. Moreover, some studies suggested that OMC can interact with the hypothalamo-pituitary-thyroid (HPT) axis.

Moreover, a study of offspring of dams treated with OMC (5001000 mg/kg/day) showed sex-dependent behavioral changes, namely decreased motor activity in females, but not in males, and improved spatial learning in males, suggesting that OMC can affect neuronal development, however the doses used in these experiments were extremely high, not relevant to possible human exposure.

Note: Study and data for tropical use only

Warning: High dosage shall be avoided as reproductive system, thyroid and behavioral alterations in animal studies has been found, Tropical usage in breast area shall be avoided to prevent the OCTINOXATE passing orally in Infants.

Octisalate and Breastfeeding

Low Risk

Octyl salicylate is an oil soluble chemical sunscreen agent that absorbs UVB radiation. It does not protect against UVA. Octyl salicylate is used to augment the UVB protection in a sunscreen. Salicylates are weak UVB absorbers and they are generally used in combination with other UV filters

Octisalate rarely causes allergies in tropical usage. Not much study has been done on effects of topical usage of Octisalate during breast feeding however it is known to penetrate the skin hence its better to use other alternatives.

FDA study found blood levels 10 times above cutoff for systemic exposure, skin penetration in lab studies has been observed

Note: Study and data for tropical use only

Warning: Tropical usage in breast area shall be avoided to prevent the Octisalate passing orally in Infants.

Octocrylene and Breastfeeding

Safe

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

Warning: Tropical usage in breast area shall be avoided to prevent the Octocrylene passing orally in Infants. In some rare cases it can cause skin allergy.


What should I do if already breastfed my kid after using Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick?

We have already established that Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick is unsafe in breastfeeding and breastfeeding while using Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick is not a good idea however if have already used and then breastfed the baby then you shall monitor the behavior and health of baby closely and inform your doctor as soon as possible. In case of emergency please call 911.


My doctor has prescribed me Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick, what should I do?

If your doctor knows that you are breastfeeding mother and still prescribes Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick then there must be good reason for that as Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick is considered unsafe, It usually happens when doctor finds that overall advantage of taking outweighs the overall risk.


If I am using Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick, will my baby need extra monitoring?

Yes, Extra monitoring is required if mother is using Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick and breastfeeding as it is considered unsafe for baby.


Who can I talk to if I have questions about usage of Orgaplus Ultra Pure Sun Ex 15g | Octinoxate, Octisalate, Octocrylene Stick in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week