Active Ingredients
Zinc Oxide 19.0%
Roe Wellness Spf 50 Mineral Powder
FDA Label NDC 82723-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aopline Health Industry Technology (guangzhou) Co., Ltd. for the product Roe Wellness Spf 50 Mineral Powder (NDC 82723-003). 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, inactive ingredients, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
Uses : Helps prevent sunburn . Higher SPF gives more sunburn protection .
Warnings
Warning : For external use only . Do not use on broken or damaged skin . Stop use and ask a doctor if rash occurs When using this product keep out of eyes . Rinse with water to remove . Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .
Directions
Directions : Apply liberally 15 minutes before sun or water exposure
Immediately after towel drying
At least every 2 hoursChildren under 6 months : Ask a doctor
Other Information
Other Information : Sun alert : Limiting sun exposure , wearing protective clothing , using sunscreens may reduce the risks of skin aging , skin cancer , and other harmful effects of the sun
Inactive Ingredients
Inactive Ingredients : Water , Ethylhexyl Olivate , Dimethicone , C9-12 Alkane , Cocoglycerides , Hydroxyethyl Dimeth Laurate , Pentylene Glycol , Butyloctyl Salicylate , Glycerin , Jojoba Esters , Pyrus Malus ( Apple ) Fruit Extract , Polymethylsilsesquioxane , Squalane , Dipotassium Glycyrthizate , Beta Vulgaris ( Beet ) Root Extract , Fructooligosaccharides , Glycine Soja ( Soybean ) Seed Extract Diheptyl Succinate, Disteardimonium Hectorite , Phenoxyethanol , Sodium Chloride , Polyhydroxystearic Acid, Trihydroxystearin , Triethyl Citrate , Hydroxyacetophenone , Sodium Citrate , Tetrasodium Glutamate Diacetate , Sodium Dehydroacetate , Capryloyl Glycerin / Sebacic Acid Copolymer
Keep Out Of Reach Of Children.
Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .
Stop Use
Stop use and ask a doctor if rash occurs When using this product keep out of eyes . Rinse with water to remove .
Otc - When Using
When using this product keep out of eyes . Rinse with water to remove . Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .
Do Not Use
Do not use on broken or damaged skin .
Package Label
82723-003-01
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