The following Structured Product Label (SPL) was submitted to the FDA by Hongkong Jiahe International Holding Limited for the product Anessa Perfect Uv Sunscreen Skincare (NDC 87719-001). 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 - keep out of reach of children, warnings, dosage & administration, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS PURPOSE
Ethylhexyl Salicylate4%................................................................ Sunscreen
Homosalate 8%................................................................................. Sunscreen
Octocrylene8%............................................. Sunscreen
Sunscreen
Uses:
Helps prevent sunburn, decreases the risk of skin cancer and early skin aging if used as directed.
Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.
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. In case of ingestion, get medical help or
contact a Poison Control Center right away.
Apply evenly to clean, dry skin before sun exposure. Apply once-daily.
Water, Dimethicone, Diisopropyl Sebacate, Homosalate, Isohexadecane, Silica, Alcohol, Octocrylene, Ethylhexyl Salicylate, Dipropylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Polysilicone-15, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C12-15 Alkyl Benzoate, Ethylhexyl Triazone, Dextrin Palmitate, Sorbitan Sesquiisostearate, Glycerin, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Trimethylsiloxysilicate, Disteardimonium Hectorite, Isostearic Acid, PEG-9 Polydimethylsiloxyethyl Dimethicone Other Trace Ingredients: Sodium Citrate, Tocopherol (Vitamin E), EDTA Trisodium, BHT, Fragrance (Parfum), Butylene Glycol, Synthetic Fluorphlogopite, Stearic Acid, PEG/PPG-14/7 Dimethyl Ether, PEG/PPG-9/2 Dimethyl Ether, Dipotassium Glycyrrhizate, PEG-6, Camellia Sinensis Leaf Extract, Potentilla Erecta Root Extract, Acetylated Sodium Hyaluronate, Soluble Collagen, Phenoxyethanol
event of prolonged sun exposure, apply standard sunscreen as-needed
throughout day
Labeling (87719 001 01)
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