PREQUEL SUN BARRIER MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- mineral sunscreen cream

Prequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Prequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 50 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

Zinc Oxide 18%

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 generously 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), Caprylic/Capric Triglyceride, Diisooctyl Succinate, Butyloctyl Salicylate, Propanediol, Glycerin, Cetearyl Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Bisabolol, Pongamia Pinnata Seed Extract, Zingiber Officinale Root Extract, Tetrahydrodiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower Extract, Centella Asiatica Extract, Phenoxyethanol, Polyglyceryl-4 Laurate/Succinate, Lauroyl Lysine, Triethoxycaprylylsilane, Arachidyl Alcohol, Silica, Xanthan Gum, Potassium Cetyl Phosphate, Behenyl Alcohol, Caprylyl Glycol, VP/Eicosene Copolymer, Arachidyl Glucoside, Tetrasodium Glutamate Diacetate, Ethylhexylglycerin, Tocopheryl Acetate, Cetyl Alcohol, Tin Oxide, Isononyl Isononanoate, Ethylene/Propylene/Styrene Copolymer, Soribitan Oleate, Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxides (CI 77499, CI 77491)

Other Information

protect the product in this container from excessive
heat and direct sun

Questions?

Visit prequelskin.com

Keep out of reach of children

Keep out of reach of children

Prupose

Sunscreen

Principal Display Panel

INGREDIENTS AND APPEARANCE

PREQUEL SUN BARRIER MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
mineral sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82800-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIISOCETYL ADIPATE (UNII: 14885YC9LU)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SORBITAN OLIVATE (UNII: MDL271E3GR)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)
TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)
TETRAHYDRODEMETHOXYDIFERULOYLMETHANE (UNII: 44D8X9U00T)
TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE (UNII: 973IBV8W7I)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAMELLIA SINENSIS SEED (UNII: MRL49Z8AC4)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 LAURATE/SUCCINATE (UNII: KAB6DS9SBS)
LAUROYL LYSINE (UNII: 113171Q70B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
SILICON (UNII: Z4152N8IUI)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETYL ALCOHOL (UNII: 936JST6JCN)
STANNIC OXIDE (UNII: KM7N50LOS6)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82800-010-01	1 in 1 PACKAGE	09/21/2023
1		50 g 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	09/21/2023

Labeler - The Center Brands, LLC (076228814)