Active Ingredient(S)
7.5% Ethylhexyl Methoxycinnamate
3% Ethylhexyl Salicylate
3% Butyl Methoxydibenzoylmethane
1% Titanium Dioxide
Sunscreen Spf 50 Cream
FDA Label NDC 84148-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ariel Biotech Co., Ltd. for the product Sunscreen Spf 50 (NDC 84148-020). 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 ingredient(s), purpose, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Preventing Skin Aging
Warnings
For external use only.
Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product, keep out of eyes. If contact occurs, rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if a 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.
Other Information
• store at room temperature
Inactive Ingredients
Water, Coco-caprylate/caprate, Propanediol, Isoamyl Laurate,
Diethylamino Hydroxybenzoyl Hexyl Benzoate, Silica, Neopentyl
Glycol Diheptanoate,C12-15Alkyl Benzoate, Polysilicone-11,
Arachidyl Alcohol, Tocopheryl Acetate, Niacinamide,
Phenoxyethanol, Polysorbate60, BehenylAlcohol, Ammonium
Acryloyldimethyltaurate/vp Copolymer,Xanthan Gum, Sodium
Hyaluronate, Arachidyl Glucoside, Butylene Glycol,
Ethylhexylglycerin, Dimethicone, Bht, Saururus Chinensis
Leaf/root Extract, Taraxacum Officinale (Dandelion) Leaf Extract,
1,2-hexanediol, Hydroxyacetophenone
Use
Use helps prevent sunburn
Directions
Apply generously 15 minutes before sun exposure.
Reapplication Guidelines:
Reapply after 80 minutes of swimming or sweating
Reapply immediately after towel drying
Reapply at least every 2 hours
For children under 6 months: Consult a doctor.
Package Label - Principal Display Panel
Undefined (Label)
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