PRISMA PROTECT SPF 30- avobenzone, homosalate, octisalate, and octocrylene lotion 
Dermalogica, Inc.

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.

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Prisma Protect SPF 30

Drug Facts

Active Ingredients

Avobenzone (3.0%)
Homosalate (10.00%)
Octisalate (5.00%)
Octocrylene (10.00%)

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

  • on damaged or broken skin.

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

  • if rash occurs.

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

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.

Questions or comments?

Call toll free 1-800-831-5150 in the US.

PRINCIPAL DISPLAY PANEL - 12 mL Tube Carton

prisma
protect

SPF
30
broad spectrum

dermalogica

light-activated skin defense

0.4 US FL OZ / 12 mL ℮

PRINCIPAL DISPLAY PANEL - 12 mL Tube Carton
PRISMA PROTECT SPF 30 
avobenzone, homosalate, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-805
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-805-041 in 1 CARTON03/07/2019
1177 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68479-805-0250 mL in 1 TUBE; Type 0: Not a Combination Product03/07/2019
3NDC:68479-805-0112 mL in 1 TUBE; Type 0: Not a Combination Product03/07/2019
4NDC:68479-805-002 mL in 1 POUCH; Type 0: Not a Combination Product03/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/07/2019
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
Cosway620899877MANUFACTURE(68479-805)

Revised: 3/2019
Document Id: 0ed0dcf8-9133-41e5-9e5b-2a68957b7467
Set id: b7f11dee-7824-43eb-8488-2fa453fd80bc
Version: 1
Effective Time: 20190307
 
Dermalogica, Inc.