ONE PERCENT SUNSCREEN cream

ONE PERCENT Sunscreen by

Drug Labeling and Warnings

ONE PERCENT Sunscreen by is a Otc medication manufactured, distributed, or labeled by Beijing Keyan Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

ZINC OXIDE 10.45%

ETHYLHEXYL METHOXYCINNAMATE 8.49405%

TITANIUM DIOXIDE 3.9%

ALUMINUM HYDROXIDE 0.6%

ETHYLHEXYL SALICYLATE 4%

PHENYLBENZIMIDAZOLE SULFONIC ACID 1%

Purpose

Sunscreen

Use

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

Do not use on damaged or broken skin.

WHEN USING

When using this product
keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Posion Control Center right away.
May stain some fabrics.

Directions

1. Clean the face
2. Moisturizing and hydrating
3. Apply sunscreen

Other information

Other information protect this product from excessive heat and direct sun

Inactive ingredients

WATER, CYCLOPENTASILOXANE, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE, GLYCERIN, SODIUM CHLORIDE,

TRIETHANOLAMINE, BHT, ISODODECANE, STEARIC ACID, PHENYL TRIMETHICONE, POLYMETHYLSILSESQUIOXANE,

BUTYLENE GLYCOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, SILICA, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, TRIMETHYLSILOXYSILICATE,

PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, DEXTRIN PALMITATE, PROPYLENE CARBONATE,

ETHYLHEXYLGLYCERIN

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ONE PERCENT SUNSCREEN 
one percent sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85176-001
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ETHYLHEXYL METHOXYCINNAMATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	ETHYLHEXYL METHOXYCINNAMATE	8.49405 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.9 g  in 100 mL
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	0.6 g  in 100 mL
ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	ETHYLHEXYL SALICYLATE	4 g  in 100 mL
PHENYLBENZIMIDAZOLE SULFONIC ACID (UNII: 9YQ9DI1W42) (PHENYLBENZIMIDAZOLE SULFONIC ACID - UNII:9YQ9DI1W42)	PHENYLBENZIMIDAZOLE SULFONIC ACID	1 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10.45 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SILICA (UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE (UNII: PWZ1720CBH)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (UNII: 59Z907ZB69)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE SALICYLATE (UNII: H8O4040BHD)
BHT (UNII: 1P9D0Z171K)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85176-001-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/05/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/05/2025

Labeler - Beijing Keyan Biotechnology Co., Ltd. (722193632)

Establishment
Name	Address	ID/FEI	Business Operations
Beijing Keyan Biotechnology Co., Ltd.		722193632	manufacture(85176-001)