Label: INTROSTEM STEM CELL ACTIVE DEFENSE- octinoxate, homosalate, octisalate, oxybenzone and avobenzone cream
- NDC Code(s): 72104-589-83
- Packager: Lionesse USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 25, 2022
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Stop using this product
- Keep out of reach of children.
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Directions
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- After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results.
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- Reapply at least every two (2) hours.
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- 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:
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- limit time in the sun, especially from 10 a.m.-2 p.m.
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- wear long-sleeved shirts, pants, hats and sunglasses
For children under 6 months of age: Ask doctor.
- Other Information
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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
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INGREDIENTS AND APPEARANCE
INTROSTEM STEM CELL ACTIVE DEFENSE
octinoxate, homosalate, octisalate, oxybenzone and avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72104-589 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.4 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6.2 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3.1 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARIC ACID (UNII: 4ELV7Z65AP) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYSORBATE 60 (UNII: CAL22UVI4M) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) TOCOPHEROL (UNII: R0ZB2556P8) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALOE VERA LEAF (UNII: ZY81Z83H0X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) WINE GRAPE (UNII: 3GOV20705G) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72104-589-83 1 in 1 CARTON 07/27/2021 1 50 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/27/2021 Labeler - Lionesse USA, Inc. (079661431)
