CELGEN MILD SUN- octinoxate, octisalate, bemotrizinol, titanium dioxide, ethylhexyl triazone, avobenzone cream 
BBHC CO., LTD

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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76731-204

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

50g NDC: 76731-204-01 Label

CELGEN MILD SUN 
octinoxate, octisalate, bemotrizinol, titanium dioxide, ethylhexyl triazone, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76731-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.125 g  in 100 g
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4) ETHYLHEXYL TRIAZONE1.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.9 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76731-204-0150 g in 1 TUBE; Type 0: Not a Combination Product09/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/03/2020
Labeler - BBHC CO., LTD (689522401)
Registrant - STC Nara Co., Ltd (689135085)
Establishment
NameAddressID/FEIBusiness Operations
STC Nara Co., Ltd689135085manufacture(76731-204)

Revised: 9/2020
Document Id: ae604fe2-8252-555e-e053-2995a90ac018
Set id: ae604fe2-8251-555e-e053-2995a90ac018
Version: 1
Effective Time: 20200902
 
BBHC CO., LTD