PRVWORA ULTRA DEFENSE SUNSCREEN- avobenzone, octinoxate, octisalate, octocrylene cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 2.85%

Octinoxate 7.25%

Octisalate 4.50%

Octocrylene 9.50%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

DOSAGE & ADMINISTRATION

For sunscreen use:

Apply liberally 15 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 decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

Water, Silica, Propanediol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Butylene Glycol, 1,2-Hexanediol, Sodium Stearoyl Glutamate, Polyglyceryl-6 Stearate, Dimethicone, Stearyl Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrolyzed Sclerotium Gum, Polyglyceryl-3 Methylglucose Distearate, Octadecene, Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer, Microcrystalline Cellulose, Isohexadecane, Poly C10-30 Alkyl Acrylate, Ethylhexylglycerin, Polyacrylate Crosspolymer-6, Fragrance, Disodium EDTA, Xanthan Gum, Polysorbate 80, Polyglyceryl-6 Behenate, Cellulose Gum, Niacinamide, Tranexamic Acid, 4-Butylresorcinol, Gluconolactone, Mandelic Acid, D-Pentapeptide-1, Phytic Acid

OTHER SAFETY INFORMATION

Protect the product in the container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRVWORA ULTRA DEFENSE SUNSCREEN 
avobenzone, octinoxate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87482-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	72.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	95 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
1-OCTADECENE (UNII: H5ZUQ6V4AK)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ISOHEXADECANE (UNII: 918X1OUF1E)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
NIACINAMIDE (UNII: 25X51I8RD4)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
4-BUTYLRESORCINOL (UNII: 2IK4UQ3ZGA)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
MANDELIC ACID (UNII: NH496X0UJX)
FYTIC ACID (UNII: 7IGF0S7R8I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87482-001-02	1 in 1 CARTON	04/04/2026
1	NDC: 87482-001-01	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	04/04/2026

Labeler - Cellarkbio Inc. (963342221)

Registrant - Cellarkbio Inc. (963342221)

Establishment
Name	Address	ID/FEI	Business Operations
OTCM JANGHANG FACTORY		696834174	manufacture(87482-001)