Label: NEOSTRATA SKIN ACTIVE MATRIX SUPPORT SPF 30- avobenzone, octinoxate, and octisalate cream
- NDC Code(s): 58414-3042-1
- Packager: NeoStrata Company 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 September 12, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (w/w)
- Purpose
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Uses
- Helps prevent sunburn
- Broad Spectrum SPF 30
- 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
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Directions
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply sunscreen at least every 2 hours
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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 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-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor.
- Other information
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Inactive ingredients
Water, Acetyl Glucosamine, Butyloctyl Salicylate, Cyclopentasiloxane, Glyceryl Stearate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, PEG-100 Stearate, Dimethicone, Cetyl Alcohol, Nylon-12, Triacontanyl PVP, Retinol, Citric Acid, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Coffea Arabica (Coffee) Fruit Extract, DL-Alpha Tocopheryl Acetate, Rosa Damascena Flower Oil, Punica Granatum Extract, Arginine, Glycerin, Propylene Glycol, Cyclohexasiloxane, Caprylyl Glycol, Dimethiconol, Disodium EDTA, BHT, Xanthan Gum, PEG-75 Stearate, Ceteth-20, Steareth-20, Polysorbate 20, Triethyl Citrate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Methyldihydrojasmonate, Carbomer, Ethylene Brassylate, Phenoxyethanol, Chlorphenesin, Yellow 5 (CI 19140), Red 33 (CI 17200).
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- PRINCIPAL DISPLAY PANEL - 50 g Tube Carton
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INGREDIENTS AND APPEARANCE
NEOSTRATA SKIN ACTIVE MATRIX SUPPORT SPF 30
avobenzone, octinoxate, and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58414-3042 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) N-ACETYLGLUCOSAMINE (UNII: V956696549) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SHEA BUTTER (UNII: K49155WL9Y) PEG-100 STEARATE (UNII: YD01N1999R) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) NYLON-12 (UNII: 446U8J075B) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) RETINOL (UNII: G2SH0XKK91) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13) ARGININE (UNII: 94ZLA3W45F) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PEG-75 STEARATE (UNII: OT38R0N74H) CETETH-20 (UNII: I835H2IHHX) STEARETH-20 (UNII: L0Q8IK9E08) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) POLYSORBATE 20 (UNII: 7T1F30V5YH) XANTHAN GUM (UNII: TTV12P4NEE) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58414-3042-1 1 in 1 CARTON 07/18/2013 1 50 g in 1 TUBE; 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 07/18/2013 Labeler - NeoStrata Company Inc. (605754829)
