Cosrx Lotion
FDA Label NDC 70319-220

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosrx Inc. for the product Cosrx (NDC 70319-220). 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 otc - active ingredient, otc - purpose, otc - when using, warnings, description, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Otc - When Using

→ Warnings

→ Description

→ Other Safety Information

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Otc - Active Ingredient

Avobenzone 2.5%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 9.0%

Otc - Purpose

Sunscreen

Otc - When Using

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 damanged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Description

Apply liberally 15 minutes before sun exposure
Children under 6 months of age : Ask a doctor.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.
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. - 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Safety Information

Protect the product in this container from excessive heat and direct sun.
Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredient

Water / Aqua / Eau, Propanediol, Butyloctyl salicylate, Diphenylsiloxy phenyl trimethicone, Dimethicone, VP/Eicosene copolymer, Silica, Trisiloxane, Cyclopentasiloxane, Trimethylsiloxysilicate, 1,2-Hexanediol, Behenyl alcohol, Glyceryl stearate, PEG-100 stearate, C14-22 alcohols, Cetyl alcohol, Potassium cetyl phosphate, Polyacrylate-13, Polyisobutene, Fragrance / Parfum, C12-20 Alkyl glucoside, Butylene glycol, Disodium EDTA, Ethylhexylglycerin, Polysorbate 20, Sorbitan isostearate, Dextrin, Theobroma cacao (cocoa) extract, Gossypium herbaceum (cotton) extract, Glucose, Tocopherol