PREQUEL SUN BARRIER MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- mineral sunscreen cream 
The Center Brands, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

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

Principal Display Panel

82800-010-01

PREQUEL SUN BARRIER MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
mineral sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82800-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82800-010-011 in 1 PACKAGE09/21/2023
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/21/2023
Labeler - The Center Brands, LLC (076228814)

Revised: 9/2023
Document Id: 05e5bf17-62d6-1eca-e063-6294a90a38b5
Set id: cd35ae20-d5b7-479d-8a5e-0278eae9e83c
Version: 1
Effective Time: 20230921
 
The Center Brands, LLC