Sunscreen Lotion
FDA Label NDC 55550-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Total Resources International for the product Sunscreen (NDC 55550-102). 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, uses, active ingredients, directions, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn

Active Ingredients

Homosalate (6.0%), Octinoxate (7.5%), Octisalate (5.0%), Oxybenzone (5.0%)

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
  • protect from excessive heat and direct sun

Warnings

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - When Using

When using this product

  • keep out of eyes
  • rinse with water to remove

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, contact a poison control center right away

Inactive Ingredients

cetyl alcohol, ganex P-904, germaben II, polyoxyl 40 stearate, polysorbate 60, petrolatum, purified water, sorbitan monostearate, tetrasodium EDTA, titanium dioxide, xanthan gum, zenicone XX

Principal Display Panel – Packet

Sunscreen Lotion
SPF 30

1.5 g. (0.0570 oz.)

Principal Display Panel – Packet (Tot02 0000 01)

Principal Display Panel – Packet (Tot02 0000 01)

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