FDA Label for Spf50 Plus Mineral Sunscreen

View Indications, Usage & Precautions

Spf50 Plus Mineral Sunscreen 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.

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Drug Facts

Dist. by KAS Direct, LLC
1525 Howe St., Racine, WI 53403


Active Ingredients



Titanium dioxide 3.5%, Zinc oxide 7.25%


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 and spread evenly by hand 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • do not spray directly into face. Spray on hands then apply to face.
    • 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, isododecane, caprylic/capric triglyceride, isohexadecane, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, shea butter ethyl esters, carthamus tinctorius (safflower) seed oil, C30-38 olefin/isopropyl maleate/MA copolymer, butyloctyl salicylate, coco-glucoside, cetearyl alcohol, cetearyl glucoside, cetearyl olivate, sorbitan olivate, ethylhexylglycerin, simmondsia chinensis (jojoba) seed oil

Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic.

, sodium hydroxide, chlorphenesin, xanthan gum, tocopherol, glycerin, sodium phytate, helianthus annuus (sunflower) seed oil, solanum lycopersicum (tomato) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (raspberry) seed oil, citric acid


Principal Display Panel - 236 Ml Bottle Label



non
allergenic

tear
free

babyganics®

SPF 50
mineral
sunscreen

pediatrician tested

broad spectrum SPF 50
water resistant (80 minutes)

made without oxybenzone, octinoxate,
parabens, fragrance, nano-particles

Discover which of our ingredients are
Certified Organic on back panel.

8 FL OZ (236 mL)

1147142


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