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  5. Label Information: Premium Natural Sunscreen Broad Spectrum Spf 30 Baby Bum

FDA Label for Premium Natural Sunscreen Broad Spectrum Spf 30 Baby Bum

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premium Natural Sunscreen Broad Spectrum Spf 30 Baby Bum Product Label

The following document was submitted to the FDA by the labeler of this product Baxter Laberatories. 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.

Otc - Active Ingredient



Active Ingredients         Purpose

Zinc Oxide 20%   ........... Sunscreen


Otc - Purpose



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

Otc - Keep Out Of Reach Of Children



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


Indications & Usage



Stop used and ask a doctor if rash occurs


Warnings



Warnings

For external use only

Do not use on damaged or broken skin

When using this Product: Keep out of eyes. Rinse with water to remove


Dosage & Administration



Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply: After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every2 hours
  • 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 of 15 or higher and other sun protection measures, including:
  • Limit time in the sun, especially form 10 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

Inactive Ingredient



Inactive Ingredients

Butyrospermum Parkii (shea) Butter, Caprylic/Capric Triglyceride, Cera Alba, Copernicia Cerifer(Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Blyceryl Isostearate, Polyhydroxystearic Acid, Parfum, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ricinus Communis (Castor) Seed Oil, Tocopherol


Package Label.Principal Display Panel



Premium Natural Sunscreen Stick

Baby Bum 30

Broad Spectrum SPF 30

Water Resistant (80minutes

.45 OZ / 13 G


* Please review the disclaimer below.