Introstem ® Stem Cell Active Defense Cream

Manufacturer
Lionesse USA, Inc.
Effective date
2022-07-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:55:40

Label at a glance#

ProductIntrostem Stem Cell Active Defense
Active ingredientOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE
Label structure10 sections

Indications and uses

• Helps prevent sunburn.

Dosage and administration

• 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 S...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  1. Helps prevent sunburn.

Warnings

WARNINGS SECTION

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

OTC - STOP USE SECTION

  • and ask doctor if rash or redness develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  1. After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results.
  2. Reapply at least every two (2) hours.
  3. 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:

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

For children under 6 months of age: Ask doctor.

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INTROSTEM®


STEM CELL ACTIVE DEFENSE
Dèfense Active Cellules Souches SPF 30
BROAD SPECTRUM SPF 30

infused with grape stem extract

50g ǀ 1.76oz


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

image-01
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Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72104-589-832022-08-09C16284748780-1e4f33bdf-a215-d8a0-e053-dadaa90a6e4eIntrostem ® Stem Cell Active Defense Cream
72104-589-832022-07-29C16284748780-1e4f33bdf-a215-d8a0-e053-dadaa90a6e4eIntrostem ® Stem Cell Active Defense Cream

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72104-58972104-589-83

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ede543b1-9669-4a57-bd70-28fbf37d69599034d0e5-4970-4d5a-b606-824b672a53132024-09-23WarningsExact identifier
spl set id: 9034d0e5-4970-4d5a-b606-824b672a5313