FDA Label for Suncare Essentials

View Indications, Usage & Precautions

Suncare Essentials 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.

Other



SPF 50+ sunscreen lotion

Drug Facts

SPF 50+ sunscreen stick

Drug Facts

dist. by KAS direct, LLC
1600 Stewart Avenue
Westbury, NY 11590


Active Ingredients



Octisalate 5.0%, Titanium Dioxide 3.0%, Zinc Oxide 6.0%

Titanium Dioxide 7.9%, Zinc Oxide 6.7%


Purpose



Sunscreen

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
    • 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

For external use only


Otc - Do Not Use



Do not use on damaged or broken skin

Do not use on damaged or broken skin


Otc - When Using



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

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

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.

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
        • apply liberally and evenly 15 minutes before sun exposure
        • reapply:
          • after 80 minutes of swimming or sweating
          • immediately after towel drying
          • at least every 2 hours
          • this product is meant for targeted protection and small areas of exposed skin
          • for full protection use in conjunction of another sunscreen lotion or spray
          • 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

  • protect this product from excessive heat and direct sun
  • keep card for full drug facts

Inactive Ingredients



water, butyloctyl salicylate, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, stearyl/octyldodecyl citrate crosspolymer, polyglyceryl-2 stearate, simmondsia chinensis (jojoba) seed oil

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

, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, glyceryl stearate, cetyl alcohol, cocos nucifera (coconut) oil, glycerin, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil, butyrospermum parkii (shea) butter, jojoba esters, stearyl alcohol, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, polyhydroxystearic acid, xanthan gum, silica, alumina, ethylhexylglycerin, trisodium ethylenediamine disuccinate, phenoxyethanol

C12-15 alkyl benzoate, caprylic/capric triglyceride, beeswax

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

, copernicia cerifera (carnauba) wax, neopentyl glycol diethylhexanoate, tribehenin, euphorbia cerifera (candelilla) wax, PPG-3 benzyl ether myristate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, helianthus annuus (sunflower) seed wax, myristyl myristate, stearyl/octadodecyl citrate crosspolymer, simmondsia chinensis (jojoba) seed oil, polyglyceryl-10 pentaoleate, jojoba esters, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (raspberry) seed oil, polyhydroxystearic acid, caprylyl glycol, ethylhexylglycerin, silica, alumina


Principal Display Panel - Kit Package



babyganics

suncare essentials
SPF 50+

we've got
you covered
from head
to toe!

SPF 50+ sunscreen lotion
6 FL OZ (177mL)

SPF 50+
sunscreen stick
Net wt 0.47 OZ (13 g)


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