PRISMA PROTECT SPF30- homosalate, octocrylene, octisalate, and avobenzone lotion 
Dermalogica, LLC.

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 SPF30

Drug Facts

Active Ingredients

Avobenzone (3.0%)
Homosalate (10.0%)
Octisalate (5.0%)
Octocrylene (10.0%)

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, Butylene Glycol, Silica, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Butyloctyl Salicylate, Polyglyceryl-2 Distearate, VP/Eicosene Copolymer, Chlorella Vulgaris Extract, Zingiber Officinale (Ginger) Root Oil, Camellia Sinensis Leaf Extract, Tocopheryl acetate, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Arachidyl Alcohol, Dimethicone Crosspolymer, Behenyl Alcohol, Caprylic/Capric Triglyceride, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arachidyl Glucoside, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Citric Acid, Sodium Citrate, Caprylyl Glycol, Polyvinyl Alcohol, 1,2-Hexanediol, Pentylene Glycol, Propanediol, Saccharide Isomerate, Bisabolol, Sodium Hydroxide, Potassium Sorbate, Sodium Benzoate, Lactic Acid/Glycolic Acid Copolymer, Heptapeptide-15 Palmitate, Limonene.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

prisma
protect

dermalogica

SPF
30

UVA
UVB

broad spectrum

moisturizer +
SPF 30

1.7 US FL OZ / 50 mL ℮

Principal Display Panel - 50 mL Tube Carton
PRISMA PROTECT SPF30 
homosalate, octocrylene, octisalate, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-851
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene10 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Dimethicone (UNII: 92RU3N3Y1O)  
Glycerin (UNII: PDC6A3C0OX)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Polyglyceryl-2 Distearate (UNII: 1XAX7BOH4W)  
Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3)  
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Pentylene Glycol (UNII: 50C1307PZG)  
Propanediol (UNII: 5965N8W85T)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
Saccharide Isomerate (UNII: W8K377W98I)  
Docosanol (UNII: 9G1OE216XY)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Xanthan Gum (UNII: TTV12P4NEE)  
Levomenol (UNII: 24WE03BX2T)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
Ethylhexylglycerin (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
Ginger Oil (UNII: SAS9Z1SVUK)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Chlorella Vulgaris (UNII: RYQ4R60M02)  
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990)  
Limonene, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-851-021 in 1 CARTON11/12/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68479-851-011 in 1 CARTON11/12/2021
212 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:68479-851-04117 mL in 1 TUBE; Type 0: Not a Combination Product11/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/12/2021
Labeler - Dermalogica, LLC. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
Cosway052400223MANUFACTURE(68479-851)
Establishment
NameAddressID/FEIBusiness Operations
McKenna090631412MANUFACTURE(68479-851)

Revised: 10/2022
Document Id: 47cb5545-95f3-40a6-8813-78e4cb9a2407
Set id: 713bad2e-bf32-4cd5-9630-b8d88d437686
Version: 1
Effective Time: 20221011
 
Dermalogica, LLC.