FDA records indicate that there are no current recalls for this drug.
Babyganics Sunscreen 30 SPF
Babyganics Sunscreen SPF 30 is designed to shield your child’s skin from UV rays and protects against skin cancer, premature aging, and other health issues caused by overexposure to sunlight. In 2008, the FDA issued a warning regarding phenoxyethanol - a chemical preservative contained in this product - stating that it can cause health problems if ingested by infants.
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Babyganics Sunscreen 30 SPF Recall
If you are a parent worried about the health of your young child you may hold concerns about the ingredients in Babyganics brand sunscreen. While the FDA has not recalled or issued warnings for this product, many parents have expressed concern over some of the ingredients. In 2014, the author of Gimme the Good Stuff - a popular parenting blog - pointed out the following surprising ingredients: octinoxate, phenoxyethanol, polysorbate-60, and lauryl PEG/PPG-18/18 methicone. Safemama.com - another popular healthy parenting resource - also called out the sunscreen stating that the product “contains phenoxyethanol, PEG’s and has a few chemical sunscreen ingredients as well”. Goodguide.com gave the product an overall score of “poor” because of ingredients that it listed as having a “medium” health risk according to its ranking system (where it receives 4.0/10.0 points). The main ingredient used in Babyganics sunscreen that Goodguide.com claims could be harmful is phenoxyethanol - an ether alcohol that is used as a preservative in cosmetics, lotions, and other products that inhibits bacterial growth.
It may be hard to wade through this information and find out if Babyganics is indeed safe for your child. To understand why it has received the negative attention that it has you need to understand where the concern about the product started - and it all goes back to phenoxyethanol.
In 2008, the FDA issued a warning about the chemical stating that it could cause health problems if ingested by infants. However, what blogs and other resources discussing Babyganics sunscreen do not state is that this warning was based on a product called "Mommy’s Bliss" - a nipple cream used by nursing mothers - that when consumed can cause vomiting and diarrhea that can lead to severe dehydration in babies. Phenoxyethanol is found in small amounts in many lotions, cosmetics, and other items. While it could be harmful if applied directly to skin, in small quantities it has not been shown to be damaging when used topically.
Questions & Answers
Side Effects & Adverse Reactions
If your child develops a rash discontinue use immediately and be sure to contact a medical professional if the problem persists.
- For external use only.
- Do not use on damaged or broken skin.
- Keep out of eyes. Rinse with water to remove.
- Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center right away.
Legal Issues
There have been no legal cases brought against this product.
FDA Safety Alerts
No FDA safety alerts have been issued.
Manufacturer Warnings
Consult a doctor before use if your child is under six months of age. This product should not be used on skin that is broken or damaged. Medical help should be sought immediately if your child ingests this product.
FDA Labeling Changes
No FDA labeling changes have been released.
Uses
Babyganics sunscreen is a topical lotion that is used to protect young skin from the damaging effects of the sun. It is made without PABA or parabens and is used to protect high exposure areas. It is tear-free and non-allergenic. The mineral-based formula provides broad spectrum UVA/UVB protection. It is smooth and easy to apply making it comfortable for your child. This product is said to retain its effectiveness for up to 80 minutes.
The FDA states that “spending time in the sun increases the risk of skin cancer and early skin aging. To reduce this risk, consumers should regularly use sun protection measures”. One of these recommendations is to use a broad spectrum sunscreen with an SPF value of 15 or higher. They also recommend that folks reapply every two hours when exposed for long periods of time - and even more often during water activities.
History
Babyganics was founded when Kevin - one of the owners - was about to welcome his first child. He could not find products that he felt were natural and safe so he decided to design his own using ingredients he could trust. Since its small beginning, Babyganics has added detergents, soaps, sunscreens, wipes, diapers, shampoos, and more to its selection of products. The company continues to grow and is known as a business that creates gentle and natural items for babies and young children. Babyganics is currently owned by Kas Direct LLC.
Other Information
Should you use Babyganics sunscreen for your child?
It depends. So far there is no evidence that it could be harmful unless ingested. Advertisements for this sunscreen imply that it is created with only “natural” ingredients such as mineral barriers like zinc oxide. However, they also utilize many other ingredients that are not natural - common chemicals found in other topical creams, lotions, and cosmetics.
Despite these concerns, Babyganics meets FDA safety standards and there have been no recalls or warnings released by the FDA. If you wish to avoid potentially harmful ingredients like phenoxyethanol you may want to choose another option for sun protection.
Sources
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1
- http://babyganics.com/our-story/
- http://www.skincancer.org/prevention/sun-protection/sunscreen
- http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116900.htm
- http://www.thedermreview.com/phenoxyethanol/
Babyganics Sunscreen 30 SPF Manufacturers
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Kas Direct Llc Dba Babyganics
Babyganics Sunscreen 30 SPF | Kas Direct Llc Dba Babyganics
apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
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