Botao - Grow Naturally Mineral Sunscreen Clear Facial Stick For Babies And Kids Spf 50 Stick
FDA Label NDC 69435-1508

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Peer Pharm Ltd. for the product Botao - Grow Naturally Mineral Sunscreen Clear Facial Stick For Babies And Kids Spf 50 (NDC 69435-1508). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product,, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Zinc Oxide 24.5 %

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 useon damaged or broken skin
  • When using this productkeep 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

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 or irritation develops and lasts.

Keep Out Of Reach Of Children.

If swallowed, call a poison control center or get medical help 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:
    •limiting time in the sun, especially from 10 a.m to 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses
    •children under 6 months: ask a doctor.

Other Information

Protect this product in this container from excessive heat and direct sun. Do not use if the seal is broken.

Inactive Ingredients

Caprylic/Capric Triglyceride, Coco-Caprylate, Ozokerite, Butyloctyl Salicylate, Polyhydroxystearic Acid, Tocopherol, Cocos Nucifera (Coonut) Oil, Triethoxycaprylylsilane, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Water (Aqua), Bisabolol, Butyrospermum Parkii (Shea) Butter, Calendula Offcinalis(Calendula) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract.

Questions Or Comments

Call 951-297-7976 or visit www.botaobaby.com

Product Label

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