Label: PRISMA PROTECT SPF 30- avobenzone, homosalate, octisalate, and octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68479-805-00, 68479-805-01, 68479-805-02, 68479-805-04 - Packager: Dermalogica, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 7, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
- helps prevent sunburn
- if used as directed with other sun care 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 30 minutes before sun exposure
- Reapply at least every two hours
- Use a water-resistant sunscreen if swimming or sweating
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and take 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-sleeve shirts, pants, hats and sunglasses
- Do not use on infants under 6 months old
- Other information
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Inactive ingredients
Water/Aqua/Eau, Silica, Butylene Glycol, Coconut Alkanes, Dimethicone, Glycerin, Dimethyl Capramide, Polyglyceryl-2 Stearate, VP/Eicosene Copolymer, Chlorella Vulgaris Extract, Palmitoyl Oligopeptide, Saccharide Isomerate, Zingiber Officinale (Ginger) Root Oil, Sclareolide, Tocopherol, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Coco-Caprylate/Caprate, Glyceryl Stearate SE, PEG-100 Stearate, Potassium Cetyl Phosphate, Arachidyl Alcohol, Dimethicone Crosspolymer, Behenyl Alcohol, Benzyl Alcohol, Caprylic/Capric Triglyceride, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arachidyl Glucoside, Ethylhexylglycerin, Methicone, Sodium Hydroxide, Trisodium Ethylenediamine Disuccinate, Citric Acid, Sodium Citrate, Caprylyl Glycol, Propanediol, Polyvinyl Alcohol, Sodium Benzoate, Potassium Sorbate, 1,2-Hexanediol, Phenoxyethanol.
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- PRINCIPAL DISPLAY PANEL - 12 mL Tube Carton
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INGREDIENTS AND APPEARANCE
PRISMA PROTECT SPF 30
avobenzone, homosalate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-805 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 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 100 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Silicon Dioxide (UNII: ETJ7Z6XBU4) Coconut Alkanes (UNII: 1E5KJY107T) Dimethicone (UNII: 92RU3N3Y1O) Glycerin (UNII: PDC6A3C0OX) Dimethyl Capramide (UNII: O29Y6X2JEZ) Polyglyceryl-2 Stearate (UNII: 253MC0P0YV) Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3) Chlorella Vulgaris (UNII: RYQ4R60M02) Grapefruit Oil (UNII: YR377U58W9) Saccharide Isomerate (UNII: W8K377W98I) Ginger Oil (UNII: SAS9Z1SVUK) Sclareolide (UNII: 37W4O0O6E6) Tocopherol (UNII: R0ZB2556P8) Green Tea Leaf (UNII: W2ZU1RY8B0) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Coco-Caprylate/Caprate (UNII: 8D9H4QU99H) Glyceryl Stearate SE (UNII: FCZ5MH785I) PEG-100 Stearate (UNII: YD01N1999R) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) Arachidyl Alcohol (UNII: 1QR1QRA9BU) Dimethicone Crosspolymer (450000 MPA.S at 12% in Cyclopentasiloxane) (UNII: UF7620L1W6) Docosanol (UNII: 9G1OE216XY) Benzyl Alcohol (UNII: LKG8494WBH) Medium-chain Triglycerides (UNII: C9H2L21V7U) Xanthan Gum (UNII: TTV12P4NEE) Ethyl Acrylate/Methacrylic Acid/Steareth-20 Methacrylate Copolymer (UNII: EPA1872R1N) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Ethylhexylglycerin (UNII: 147D247K3P) Methicone (20 CST) (UNII: 6777U11MKT) Sodium Hydroxide (UNII: 55X04QC32I) Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q) Citric Acid Monohydrate (UNII: 2968PHW8QP) Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR) Caprylyl Glycol (UNII: 00YIU5438U) Propanediol (UNII: 5965N8W85T) Polyvinyl Alcohol, Unspecified (UNII: 532B59J990) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) 1,2-Hexanediol (UNII: TR046Y3K1G) Phenoxyethanol (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-805-04 1 in 1 CARTON 03/07/2019 1 177 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68479-805-02 50 mL in 1 TUBE; Type 0: Not a Combination Product 03/07/2019 3 NDC:68479-805-01 12 mL in 1 TUBE; Type 0: Not a Combination Product 03/07/2019 4 NDC:68479-805-00 2 mL in 1 POUCH; Type 0: Not a Combination Product 03/07/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/07/2019 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations Cosway 620899877 MANUFACTURE(68479-805)
