PRISMA PROTECT SPF30- homosalate, octocrylene, 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

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

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, 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 ℮

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-851
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	10 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-851-02	1 in 1 CARTON	11/12/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-851-01	1 in 1 CARTON	11/12/2021
2		12 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68479-851-04	117 mL in 1 TUBE; Type 0: Not a Combination Product	11/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	11/12/2021

Labeler - Dermalogica, LLC. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		052400223	MANUFACTURE(68479-851)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna		090631412	MANUFACTURE(68479-851)