Spf 50 Plus Sunscreen Stick
FDA Label NDC 87807-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Theravita Llc for the product Spf 50 Plus Sunscreen (NDC 87807-001). 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 ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - 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

Other

Drug Facts

Theravita LLC

Valley Stream, NY 11580

USA

Active Ingredients

Avobenzone 3%

Octocrylene 8%

Octisalate 5%

Octinoxate 7.5%

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 use

• on damaged or broken skin.

Otc - When Using

When using this productkeep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor ifrash occurs

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.

    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. to 2 p.m.

    • wear long-sleeved shirts, pants, hats and sunglasses.

    Children under 6 months:

    Ask a doctor.

Other Information

  • protect this product from excessive heat and direct sun
  • keep outer card for full drug facts

Inactive Ingredients

  • Ethylhexyl Palmitate
  • Synthetic Wax
  • Polyethylene
  • * Microcrystalline Wax
  • * Polyglyceryl-10 Stearate
  • * Hydrogenated Polyisobutene
  • * Silica
  • * Tocopherol (Vitamin E)
  • * Bisabolol
  • * Aloe Barbadensis Leaf Extract
  • * Fragrance (optional)
  • * Phenoxyethanol
  • * Caprylyl Glycol
  • * Ethylhexylglycerin

Principal Display Panel - 15 G

THERAVITARX Sunscreen Stick

Broad Spectrum SPF 50+ PA+++

Net Weight: 15 g (0.53 oz)

For external use only.

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