Active Ingredients
Homosalate 6%, Octinoxate 7.5%, Octisalate 5%, Oxygenzone 5%
1177, 1178 Sunscreen Cream
FDA Label NDC 67777-177
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex for the product 1177, 1178 Sunscreen (NDC 67777-177). 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, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
. Protects from excessive heat and direct sun
. Helps prevent sunburns
. Higher SPF gives more sunburn protection
. For skin highly sensitive to sunburn
Warnings
For External Use Only.
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 carcer or early skin aging.
Do Not Use
On damaged or broken skin
When Using This Product
. Keep out of eyes
. Rinse with water to remove
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 at least every 2 hours
. Children under 6 months: as a doctor
Inactive Ingredients
Antaron V-220, Cetyl Alcohol, Germaben II-E, PEG-8 Dimethicone, Petrolatum, Polyoxyl 40 Stearate, Polysorbate 60, Purified Water, Sorbitan Monostearate, Tetrasodium EDTA, Titanium Dioxide, Xanthan Gum
Label
* Please review the disclaimer below.
