Otc - Active Ingredient
Zinc Oxide - 13.0%
Sonage Roux Tinted Day Creme With Spf 30 Lotion
FDA Label NDC 69546-313
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 Roux Tinted Day Creme With Spf 30 (NDC 69546-313). 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, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, 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.
Warnings
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.
Otc - Keep Out Of Reach Of Children
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.
Use a water resistant sunscreen if swimming or sweating
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
Arachidyl Alcohol, Arachidyl Glucoside, Astrocaryum Tucuma Seed Butter, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cedrus Alantica Wood (Cedarwood) Oil, Ceramide NP, Cetearyl Alcohol, Cetyl Palmitate, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Coco-Glucoside, Ethyl Ferulate, Glycerin, Iron Oxides, Neopentyl Glycol Diheptanoate, Niacinamide, Octyldodecyl Oleate, Palmitoyl Hexapeptide-12, Pogostemon Cablin (Patchouli) Oil, Polyhydroxystearic Acid, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Sorbitan Olivate, Sorbitan Palmitate, Squalane, Tocopherol, Trehalose, Water, Xanthan Gum
Other Information
Protect this product from excessive heat and direct sun.
Package Label.Principal Display Panel
1 (Sonage)
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