Premium Natural Sunscreen Broad Spectrum Spf 30
FDA Label NDC 70157-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Baxter Laberatories for the product Premium Natural Sunscreen Broad Spectrum Spf 30 (NDC 70157-007). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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