Otc - Active Ingredient
Zinc Oxide - 15.7%
Sonage Protec Plus Spf 30 Mineral Sunscreen Lotion
FDA Label NDC 69546-322
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Asa Universal Inc. Dba: Sonage for the product Sonage Protec Plus Spf 30 Mineral Sunscreen (NDC 69546-322). 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, uses, warning, directions, inactive ingredients, other information, carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Warning
For external use only.
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 a doctor if rash occurs.
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
Reapply immediately after towel drying
Rapply at least every 2 hours.
Children under 6 monts: Ask a doctor.
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 sun glasses.
Inactive Ingredients
aloe barbadensis leaf juice, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bisabolol*, butyloctyl salicylate, butyrospermum parkii (shea) butter*, caprylhydroxamic acid, capryloyl glycerin/sebacic acid copolymer, caprylyl glycol, cellulose gum, cetearyl alcohol, cetyl alcohol, citric acid, coco-glucoside, cocos nucifera (coconut) oil, diheptyl succinate, glycerin, microcrystalline cellulose, polyhydroxystearic acid, sodium gluconate, sodiumhyaluronate, sodium stearoyl glutamate, theobroma cacao (cocoa) seed butter* , tocopherol, water
*certified organic
Other Information
Protect this product from excessive heat and direct sun.
* Please review the disclaimer below.
