Spf30 Calendula Sunscreen Lotion
FDA Label NDC 52915-067

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Organic & Sustainable Beauty for the product Spf30 Calendula Sunscreen (NDC 52915-067). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, stop use and ask a doctor if, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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.

Principal Display Panel (82 g Tube Label)

Principal Display Panel (82 g Tube Label)

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