Label: CELGEN MILD SUN- octinoxate, octisalate, bemotrizinol, titanium dioxide, ethylhexyl triazone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76731-204-01 - Packager: BBHC CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 2, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- Stop use and ask a doctor
- Keep out of reach of children
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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.
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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
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INGREDIENTS AND APPEARANCE
CELGEN MILD SUN
octinoxate, octisalate, bemotrizinol, titanium dioxide, ethylhexyl triazone, avobenzone creamProduct 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)
