Raw Elements Baby Kids Broad Spectrum Spf30 Lotion
FDA Label NDC 70680-307

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raw Elements Llc for the product Raw Elements Baby Kids Broad Spectrum Spf30 (NDC 70680-307). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Non-Nano Zinc Oxide 25%

Purpose

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

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.

Stop Use And Ask A Doctor

if rash occurs.

Keep Out Of Reach Of Children.

If product is 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
    • 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 from 10 am-2 pm
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

Inactive Ingredients

Helianthus Annuus (Organic Sunflower) Seed Oil, Cera Alba (Organic Beeswax), Cocos Nucifera (Organic Coconut) Oil, Theobroma Cacao (Organic Cocoa) Seed Butter, Calendula Officinalis (Organic Calendula) Flower Extract, Organic Chamomilla Recutita (Organic Chamomile) Flower Extract, Rosmarinus Officinalis (Natural Rosemary) Leaf Extract, Tocopherol (Natural Sunflower Vitamin E)

Other Information

  • protect this product from excessive heat and direct sun

Questions Or Comments?

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Package Labeling:

Label5 (Label5)

Label5 (Label5)

Label6 (Label6)

Label6 (Label6)

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