FDA Label for Babyganics Sunscreen 30 Spf

View Indications, Usage & Precautions

Babyganics Sunscreen 30 Spf Product Label

The following document was submitted to the FDA by the labeler of this product Kas Direct Llc Dba Babyganics. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Octinoxate 5.0%, Octisalate 4.0%, Zinc oxide 11.2%


Purpose



Sunscreen


Uses



  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings



For external use only


Otc - Do Not Use



Do not use on damaged or broken skin


Otc - When Using



When using this product keep out of eyes. Rinse with water to remove.


Otc - Stop Use



Stop use and ask a doctor if rash occurs


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • 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

Other Information



protect this product from excessive heat and direct sun


Inactive Ingredients



water, caprylic/capric triglyceride, glycerin, vp/hexadecene copolymer, aloe barbadensis leaf juice, glyceryl stearate, hexaglyceryl polyricinoleate, polysorbate 80, phenethyl alcohol, glyceryl caprylate, sodium magnesium silicate, xanthan gum, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, squalane, citric acid, lecithin, polysorbate 60, sorbitan isostearate.


Other



Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801


Principal Display Panel - 177 Ml Bottle Label



30
SPF

tear
free

water
resistant

babyganics®

mineral-based
sunscreen spray

broad spectrum SPF 30
UVA + UVB protection
water resistant (80 minutes)
non-allergenic

no: PABA, phthalates, parabens,
fragrances or nano-particles

6 FL OZ (177mL)

040-12290-01


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