FDA Label for Spf30 Calendula Sunscreen

View Indications, Usage & Precautions

Spf30 Calendula Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Organic & Sustainable Beauty. 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


Active Ingredient



Titanium Dioxide 12%


Purpose



Sunscreen


Uses



Helps prevent sunburn

  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water

Warnings



For external use only


Otc - Do Not Use



Do not use: on damaged or broken skin.


Stop Use And Ask A Doctor If



  • rash or irritation develops and lasts.

Otc - When Using



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


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 the product in this container from excessive heat and direct sunlight. Report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016


Inactive Ingredients



Water, calendula officinalis extract (calendula), isoamyl laurate, coco-caprylate, viola tricolor extract (pansy), polyglyceryl-2 dipolyhydroxystearate, euphorbia cerifera (candelilla) wax, glyceryl starch, carthamus tinctorius (safflower) oleosomes, polyglyceryl-3 diisostearate, levulinic acid, glycerin, tapioca starch, rosmarinus officinalis (rosemary) leaf extract, cocos nucifera (coconut) oil, squalane, magnesium stearate, p-anisic acid, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, allantoin, panthenol.


Principal Display Panel - 82 G Tube Label



CALIF♥RNIA BABY®
TRUSTED SINCE 1995

calendula™

30+
SUNSCREEN LOTION

HIGH PROTECTION

SUPER GENTLE & SOOTHING

BROAD SPECTRUM
SPF 30+ SUNSCREEN
WATER RESISTANT (80 MINUTES)

FOR BABIES, KIDS + ADULTS
WITH SENSITIVE SKIN

ALLERGY
TESTED

© 2018
NET WT 82 g/2.9 oz.


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