SUNSCREEN CREAM- avobenzone , homosalate ,octisalate , octocrylene lotion, augmented

Sunscreen Cream by

Drug Labeling and Warnings

Sunscreen Cream by is a Otc medication manufactured, distributed, or labeled by Shenzhen Furuizhilian keji Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%, Homosalate 6%,Octisalate 5%, Octocrylene 5%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

STOP USE

rash occurs

DO NOT USE

on damaged or broken skin

WHEN USING

keep out of eyes. Rinse with water to remone

KEEP OUT OF REACH OF CHILDREN

If product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.

INACTIVE INGREDIENT

Water, Ethylhexyl Methoxycinnamate, Butylene Glycol, Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Cetearyl Alcohol, Dicaprylyl Carbonate, Diethylhexyl Butamido Triazone, Titanium Dioxide, C20-22 Alkyl Phosphate, Aluminum Starch Octenylsuccinate, C20-22 Alcohols, Arginine, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sodium Stearoyl Glutamate, Sodium Hydroxide, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Squalane, Silica, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Allantoin, Caprylyl Glycol, Tocopherol (Vitamin E), Stearyl Glycyrrhetinate, Polysorbate 60, Disodium EDTA, Fragrance, Sorbitan Isostearate, BHT, Caprylic/Capric Triglyceride, Theobroma Cacao (Cocoa) Seed Extract, Glucose, Potassium Sorbate

DOSAGE & ADMINISTRATION

Use when going out

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN CREAM 
avobenzone , homosalate ,octisalate , octocrylene lotion, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84445-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
C20-22 ALCOHOLS (UNII: O4M0347C6A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 1.0%) (UNII: 8Z5ZAL5H3V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BEMOTRIZINOL (UNII: PWZ1720CBH)
ARGININE (UNII: 94ZLA3W45F)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
COCOA (UNII: D9108TZ9KG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISCOTRIZINOL (UNII: 2UTZ0QC864)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
OCTINOXATE (UNII: 4Y5P7MUD51)
ENSULIZOLE (UNII: 9YQ9DI1W42)
XANTHAN GUM (UNII: TTV12P4NEE)
ALLANTOIN (UNII: 344S277G0Z)
FRAGRANCE 13576 (UNII: 5EM498GW35)
POLYSORBATE 60 (UNII: CAL22UVI4M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SQUALANE (UNII: GW89575KF9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84445-005-01	50 g in 1 TUBE; Type 0: Not a Combination Product	07/16/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/16/2024

Labeler - Shenzhen Furuizhilian keji Co., Ltd. (418598613)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Furuizhilian keji Co., Ltd.		418598613	manufacture(84445-005)