PREQUEL SOLAR SHADE SUNSCREEN SPF 46- sunscreen 46 liquid

Prequel Solar Shade Sunscreen SPF 46 by

Drug Labeling and Warnings

Prequel Solar Shade Sunscreen SPF 46 by is a Otc medication manufactured, distributed, or labeled by The Center Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.0%

Homosalate 7.0%

Octisalate 5.0%

Octocrylene 9.0%

Uses

helps prevent sunburn if used as directed with other
sun protection 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 docor if rash occurs
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

apply liberally and evenly 15 minutes before sun exposure
reapply: at least every 2 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 decrease
this risk, regularly use a sunscreen with a Broad Spectrum SPF
value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
children under 6 months of age: Ask a doctor

Inactive ingredients

Water (Aqua), Glycerin, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Pongamia Glabra Seed Oil, Undecane, Betaine, Silica, Ethyl Ferulate, Oryza Sativa Extract, Oryza Sativa Germ Extract, Glycine Soja Seed Extract, Tridecane, Glycine Soja Oil, Sodium Dilauramidoglutamide Lysine, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Inulin, Fructose, Glucose, Pongamia Pinnata Seed Extract, Polyglyceryl-4 Laurate, Polyglyceryl-6 Laurate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Tuarate Copolymer, Hyroxyacetophenone, Arachidyl Alcohol, 1,2-Hexanediol, Caprylyl Glycol, Behenyl Alcohol, Cellulose Gum, Polyglyceryl-3 Diisostearate, Arachidyl Glucose, Tocopherol, Sodium Phytate, Polysorabate 60, Sorbitan Isostearate, Citric Acid, Xanthan Gum, Cellulose.

Other Information

protect the product from excessive heat and direct sun

Questions?

Visit prequelskin.com

Keep out of reach of children

Keep out of reach of children

Purpose

Sunscreen

Principal Display Panel

INGREDIENTS AND APPEARANCE

PREQUEL SOLAR SHADE SUNSCREEN SPF 46 
sunscreen 46 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82800-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
1-UNDECENE (UNII: 1446756A8F)
BETAINE (UNII: 3SCV180C9W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYL FERULATE (UNII: 5B8915UELW)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
SOYBEAN (UNII: L7HT8F1ZOD)
TRIDECANE (UNII: A3LZF0L939)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
INULIN (UNII: JOS53KRJ01)
FRUCTOSE (UNII: 6YSS42VSEV)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
POLYGLYCERYL-4 LAURATE (UNII: 82V7NG3DYT)
POLYGLYCERYL-6 LAURATE (UNII: Q48X4BL3TV)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
TOCOPHEROL (UNII: R0ZB2556P8)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
ALPHA CELLULOSE (UNII: I355QGZ19A)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82800-040-01	1 in 1 PACKAGE	07/15/2024
1		50 mg 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	07/15/2024

Labeler - The Center Brands, LLC (076228814)