Introstem Prismastem Face Shield Cream
FDA Label NDC 72104-042

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innovation Brands Inc. for the product Introstem Prismastem Face Shield Cream (NDC 72104-042). 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 ingredients, purpose, uses, warnings, stop using this product, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Octinoxate 7.40%
Homosalate 6.20%
Octisalate 5.00%
Oxybenzone 3.10%
Avobenzone 1.50%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.

Warnings

For external use only. Do not use on damaged or broken skin.

Keep out of eyes. If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician.

Stop Using This Product

and ask doctor if rash or redness develops and lasts.

Keep Out Of Reach Of Children.

If accidental ingestion, call the Poison Control Center right away.

Directions

  • After cleansing, apply liberally and evenly 15 minutes before sun exposure.
    Smooth over face and neck and chest daily for optimal results.
  • Reapply at least every two (2) hours.
  • Use 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:

    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses.

      • For children under 6 months of age: Ask doctor.

Other Information

Protect the product in this container from excessive heat and direct sun. Store at room temperature.

Inactive Ingredients

Aqua, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Triethanolamine, Fragrance, Tocopherol, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Camellia Sinensis Extract, Sodium PCA, Vitis Vinifera (Grape) Fruit Cell Extract, Disodium EDTA.

Package/Label Principal Display Panel – Carton Label

INTROSTEM®


PRISMASTEM FACE SHIELD CREAM
Crème Solaire Visage SPF 30 PrismaStem
BROAD SPECTRUM SPF 30

infused with grape stem cell extract

60g ǀ 2.1oz


www.introstem.com
20255 Corisco St.
Chatsworth, CA 91311

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