Otc - Active Ingredient
Zinc Oxide 21.96%
Goodal Heartleaf Soothing Zinc 100 Mineral Sunscreen Cream
FDA Label NDC 84532-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clio Cosmetics Co., Ltd. for the product Goodal Heartleaf Soothing Zinc 100 Mineral Sunscreen (NDC 84532-003). 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 otc - active ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn
If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun
Dosage & Administration
Apply liberally 15 minutes before sun exposure
Reapply at least every two hours
Use a water-resistant sunscreen if swimming or sweating
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: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses
Warnings
For external use only.
Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs.
When using this product keep out of eyes. Rinse with water to remove.
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
Inactive Ingredient
WATER, DIMETHICONE, PROPYLHEPTYL CAPRYLATE, METHYL TRIMETHICONE, BUTYLOCTYL SALICYLATE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ALCOHOL, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, DICAPRYLYL CARBONATE, C9-12 ALKANE, DISTEARDIMONIUM HECTORITE, METHYL METHACRYLATE CROSSPOLYMER, BENZOTRIAZOLYL DODECYL P-CRESOL, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM SULFATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, 1,2-HEXANEDIOL, SILICA, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CAPRYLYL GLYCOL, DIMETHICONOL, TRISILOXANE, OLEA EUROPAEA (OLIVE) FRUIT OIL, ETHYLHEXYLGLYCERIN, DIPROPYLENE GLYCOL, SODIUM CITRATE, ABIES SIBIRICA OIL, TOCOPHEROL, BUTYLENE GLYCOL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SALVIA SCLAREA (CLARY) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, EUGENIA CARYOPHYLLUS (CLOVE) LEAF OIL, ANTHEMIS NOBILIS FLOWER OIL, POGOSTEMON CABLIN OIL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL, JUNIPERUS MEXICANA OIL, NIACINAMIDE, CERAMIDE NP, LACTOBACILLUS FERMENT, PENTYLENE GLYCOL, GLYCERYL GLUCOSIDE, HOUTTUYNIA CORDATA EXTRACT, GANODERMA LUCIDUM (MUSHROOM) STEM EXTRACT, GLYCERIN, DIMETHYLSILANOL HYALURONATE, HYDROLYZED HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, SODIUM HYALURONATE, HYALURONIC ACID, POTASSIUM HYALURONATE, SODIUM HYALURONATE CROSSPOLYMER, HYDROXYPROPYLTRIMONIUM HYALURONATE, ACETYL HEXAPEPTIDE-8, SODIUM HYALURONATE DIMETHYLSILANOL, SODIUM ACETYLATED HYALURONATE
Other Safety Information
Protect the product in the container from excessive heat and direct sun.
Package Label.Principal Display Panel
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