Drug Facts Active Ingredient Purpose
Zinc Oxide(15.445) Sunscreen
Mild Care Suncream
FDA Label NDC 76344-8006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Humex,inc. for the product Mild Care Suncream (NDC 76344-8006). 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 drug facts active ingredient purpose, uses, warnings, directions, other information, inactive ingredients, package display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Helps prevent sunburn
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
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 (1-800-222-1222) right away.
Directions
▪ Appy liberally 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
Other Information
▪ protect the product in this container from excessive heat and direct sun
Inactive Ingredients
WATER,PROPYLHEPTYL CAPRYLATE,LAURYL POLYGLYCERYL-3POLYDIMETHYLSILOXYETHYL DIMETHICONE,ISODODECANE,ISOTRIDECYL ISONONANOATE,POLYGLYCERYL-3POLYDIMETHYLSILOXYETHYL DIMETHICONE,DISTEARDIMONIUM HECTORITE,MAGNESIUM SULFATE,TRIETHOXYCAPRYLYLSILANE,GLYCOL DIMETHACRYLATE,1,2-HEXANEDIOL,POLYHYDROXYSTEARIC ACID,GLYCERYL CAPRYLATE,CAPRYLYL GLYCOL,POLYMETHYLSILSESQUIOXANE,PANTHENOL,ETHYLHEXYLGLYCERIN,TOCOPHEROL,CERAMIDE NP,SUCROSE STEARATE,CHOLESTEROL,STEARIC ACID,CHOLESTERYL MACADAMIATE,PALMITIC ACID,SACCHARIDE ISOMERATE
Package Display Panel
Display Panel (Fda Humex Mildcaresuncream Packaging)
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