Otc - Active Ingredient
Active ingredient(s)
Zinc Oxide 19.32%
Abib Heartleaf Mild Sunscreen Relief Tube Cream
FDA Label NDC 73676-217
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fourcompany Co., Ltd. for the product Abib Heartleaf Mild Sunscreen Relief Tube (NDC 73676-217). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
Use(s)
■ 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
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
■ Keep out of reach of children, If swallowed, get medical help or contact a Poison Control Center right away.
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.
Dosage & Administration
Directions
■ Apply liberally and evenly 15 minutes before sun exposure
■ Reapply at least every 2 hours
■ Use a water-resistant sunscreen if swimming or sweating
■ Children under 6 months of age: 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. ‒ 2 p.m.
■ Wear long-sleeved shirts, pants, hats, and sunglasses
Other Safety Information
Other Information
■ Protect the product in this container from excessive heat and direct sun
Otc - Questions
Questions
Inactive Ingredient
Inactive ingredients
Water, Butyloctyl Salicylate, Propylheptyl Caprylate, Propanediol, C15-19 Alkane, Disiloxane, Isododecane, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Caprylyl Methicone, Isopropyl Myristate, Sodium Chloride, Triethylhexanoin, Glycerin, Disteardimonium Hectorite, Methyl Methacrylate Crosspolymer, Polymethylsilsesquioxane, Triethoxycaprylylsilane, 1,2-Hexanediol, Dipentaerythrityl Tri-Polyhydroxystearate, Houttuynia Cordata Extract, Lauryl Dimethicone/Polyglycerin-3 Crosspolymer, Polyglyceryl-2 Dipolyhydroxystearate, Panthenol, Caprylyl Glycol, Glyceryl Caprylate, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Coccinia Indica Fruit Extract, Butylene Glycol, Amber Powder, Solanum Melongena (Eggplant) Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Dipropylene Glycol, Ocimum Sanctum Leaf Extract, Corallina Officinalis Extract, Moringa Oleifera Seed Oil, Tocopherol, Sodium Citrate, Lecithin, Sodium Hyaluronate, Allantoin, Dipotassium Glycyrrhizate, Sodium PCA, Arginine, Ceramide NP, Erythritol, Asiaticoside, Madecassic Acid, Asiatic Acid, Centella Asiatica Extract, Pentylene Glycol, Octanediol
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