CELGEN MILD SUN- octinoxate, octisalate, bemotrizinol, titanium dioxide, ethylhexyl triazone, avobenzone cream

CELGEN MILD SUN by

Drug Labeling and Warnings

CELGEN MILD SUN by is a Otc medication manufactured, distributed, or labeled by BBHC CO., LTD, STC Nara Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethylhexyl Methoxycinnamate (6.50%)

Ethylhexyl Salicylate (4.50%)

Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (4.00%)

Titanium Dioxide (2.125%)

Ethylhexyl Triazone (1.50%)

Butyl Methoxydibenzoylmethane (0.90%)

Purpose

Sunscreen

Use

Helps to 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 doctor

if irritation occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a proper amount evenly for the last step of skin care.

Apply liberally 15 minutes before sun exposure.

Reapply at least every two hours.

Use a water resistant sunscreen if swim- ming 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) Limited time in the sun, especially from 10a.m-2p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses 3) Ask a doctor to use for children under 6 months.

Inactive ingredients

Water, Glycerin, Cyclopentasiloxane, Cetyl Ethylhexanoate, Silica, Butylene Glycol, Polymethyl Methacrylate, Dimethicone, Portulaca Oleracea Extract, Caprylhydroxamic Acid, Propanediol, Arginine, Glyceryl Stearate, PEG-100 Stearate, 1,2-Hexanediol, Caprylyl Glycol, Polysorbate 60, Carbomer, Fragrance, Red Ginseng Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Sodium Chloride, Glucose

Package Label

INGREDIENTS AND APPEARANCE

CELGEN MILD SUN 
octinoxate, octisalate, bemotrizinol, titanium dioxide, ethylhexyl triazone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76731-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.125 g  in 100 g
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4)	ETHYLHEXYL TRIAZONE	1.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.9 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PROPANEDIOL (UNII: 5965N8W85T)
ARGININE (UNII: 94ZLA3W45F)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PURSLANE (UNII: M6S840WXG5)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76731-204-01	50 g in 1 TUBE; Type 0: Not a Combination Product	09/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/03/2020

Labeler - BBHC CO., LTD (689522401)

Registrant - STC Nara Co., Ltd (689135085)

Establishment
Name	Address	ID/FEI	Business Operations
STC Nara Co., Ltd		689135085	manufacture(76731-204)