Mineral Sunscreen Broad Spectrum Spf30 Lotion
FDA Label NDC 53727-121

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmecca Korea Co., Ltd for the product Mineral Sunscreen Broad Spectrum Spf30 (NDC 53727-121). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

TITANIUM DIOXIDE 3.44%

ZINC OXIDE 4.88%

Purpose

Sunscreen

Uses

  • 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

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 swallowed. get medical help or contact a Poison Control Center right away.

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
  • Immediately after towel drying 
  • At least every 2 hours
  • Children under 6 months of age: Ask a doctor 
  • Sun Protection Measures. Spending time in the sun increases your risk of a 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.

Other Information

  • Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

WATER (AQUA), DIMETHICONE, C12-15 ALKYL BENZOATE, PROPANEDIOL, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLOCTYL SALICYLATE, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, NIACINAMDE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, OLIVE OIL POLYGLYCERYL-6 ESTERS, POLYSILICONE-11, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, PERSEA GRATISSIMA (AVOCADO) OIL, POLYGLYCERYL-6 PENAOLEATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, STEARIC ACID, ALPHA-GLUCAN OLIGOSACCHARIDE, SILICA, VITIS VINIFERA (GRAPE) SEED OIL, BISABOLOL, CAFFEINE, TRIETHOXYCAPRYLYLSILANE, ALUMINA, POLYMNIA SONCHIFOLIA ROOT JUICE, POLYHYDROXYSTEARIC ACID, MALTODEXTRIN, SODIUM HYALURONATE, PHENOXYETHANOL, LACTOBACILLUS, MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)

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