PRISMA PROTECT SPF30- octocrylene, homosalate, octisalate, and avobenzone lotion

PRISMA PROTECT SPF30 by

Drug Labeling and Warnings

PRISMA PROTECT SPF30 by is a Otc medication manufactured, distributed, or labeled by Dermalogica, LLC., Cosway, McKenna. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients w/w

Avobenzone (3%)
Homosalate (7%)
Octisalate (5%)
Octocrylene (10%)

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures, (see Directions), helps decrease 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

• After cleansing and toning, apply generously to face 30 minutes prior to 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.
• Contains phenylethyl alcohol, sorbates, and benzoates.
• Store below 77°F/25°C

Inactive ingredients

Water/Aqua/Eau, Butylene Glycol, Butyloctyl Salicylate, Silica, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, VP/Eicosene Copolymer, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Zingiber Officinale (Ginger) Root Oil, Camellia Sinensis Leaf Extract, Centella Asiatica Leaf Extract, Tocopheryl Acetate, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylic/Capric Triglyceride, Pentylene Glycol, Saccharide Isomerate, Bisabolol, Sclareolide, Arachidyl Glucoside, Arachidyl Alcohol, Xanthan Gum, Behenyl Alcohol, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Sodium Hydroxide, Citric Acid, Propanediol, Dimethicone Crosspolymer, Sodium Citrate, Potassium Sorbate, Sodium Benzoate, 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

high
protection

UVA
UVB

broad spectrum

moisturizer +
SPF 30

1.7 US FL OZ / 50 mL ℮

INGREDIENTS AND APPEARANCE

PRISMA PROTECT SPF30 
octocrylene, homosalate, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-852
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	10 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	7 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
Dimethicone (UNII: 92RU3N3Y1O)
Glycerin (UNII: PDC6A3C0OX)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Pentylene Glycol (UNII: 50C1307PZG)
Propanediol (UNII: 5965N8W85T)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Saccharide Isomerate (UNII: W8K377W98I)
Caprylyl Glycol (UNII: 00YIU5438U)
DOCOSANOL (UNII: 9G1OE216XY)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LEVOMENOL (UNII: 24WE03BX2T)
Sclareolide (UNII: 37W4O0O6E6)
Xanthan Gum (UNII: TTV12P4NEE)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Ethylhexylglycerin (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)
GINGER OIL (UNII: SAS9Z1SVUK)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
Sodium Hydroxide (UNII: 55X04QC32I)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-852-02	1 in 1 CARTON	02/09/2024
1		50 mL 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 drug	M020	02/09/2024

Labeler - Dermalogica, LLC. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		052400223	MANUFACTURE(68479-852)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna		090631412	MANUFACTURE(68479-852)