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

Prisma Protect SPF 30 by

Drug Labeling and Warnings

Prisma Protect SPF 30 by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., Cosway. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

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

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

• Apply liberally 30 minutes before sun exposure
• Reapply at least every two hours
• Use a 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 help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and take 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
• Do not use on infants under 6 months old

Other information

• Protect this product from excessive heat and direct sun.

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 ℮

INGREDIENTS AND APPEARANCE

PRISMA PROTECT SPF 30 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product 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)