Cream Oil Sunscreen Cream
FDA Label NDC 59958-408

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Owen Biosciences, Inc. for the product Cream Oil Sunscreen (NDC 59958-408). 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, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients Purpose

Zinc Oxide 21.50%...... Sunscreen

Titanium Dioxide 1.25%...... Sunscreen

Uses

Helps protect against sunburn
provides moderate protection against sunburn

Warnings

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 doctor if rash occurs

Keep out of reach of children If swallowed, get medicl help or contact poison control center.

Directions

Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: ask doctor.
Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10a.m. - 2p.m.
wear long sleeve shirts, pants, hats and sunglasses.
Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating

Other Information

Protect the product in this contianer from heat and direct sun.

* Please review the disclaimer below.