Label: ACTIBEAU CAMELLIA FLORAL CALMING SUNSCREEN- octinoxate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73016-004-01, 73016-004-02 - Packager: ACTIVEBEUTY 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 April 3, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
WATER, BUTYLENE GLYCOL, DICAPRYLYL CARBONATE, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, PROPANEDIOL, DIMETHICONE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, NIACINAMIDE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, POLYMETHYL METHACRYLATE, HYDROGENATED POLY(C6-14 OLEFIN), POTASSIUM CETYL PHOSPHATE, C14-22 ALCOHOLS, TREHALOSE, C12-15 ALKYL BENZOATE, CETEARYL ALCOHOL, PEG-100 STEARATE, BEHENYL ALCOHOL, PHENOXYETHANOL, FRAGRANCE, C12-20 ALKYL GLUCOSIDE, ALUMINUM HYDROXIDE, POLYGLYCERYL-6 POLYRICINOLEATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, POLYHYDROXYSTEARIC ACID, STEARIC ACID, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, FERRIC OXIDE YELLOW (CI 77492), XANTHAN GUM, NEOPENTYL GLYCOL DIETHYLHEXANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ADENOSINE, POTASSIUM HYDROXIDE, ETHYLHEXYLGLYCERIN, FERRIC OXIDE RED (CI 77491), DISODIUM EDTA, ZINC OXIDE, TRIETHOXYCAPRYLYLSILANE, SODIUM HYALURONATE, CAMELLIA JAPONICA SEED OIL, D&C RED NO. 33 (CI 17200), NELUMBO NUCIFERA FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, SOPHORA JAPONICA FLOWER EXTRACT, CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER EXTRACT, CAMELLIA JAPONICA FLOWER EXTRACT, PRUNUS MUME FLOWER EXTRACT, PYRUS COMMUNIS (PEAR) FLOWER EXTRACT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACTIBEAU CAMELLIA FLORAL CALMING SUNSCREEN
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73016-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 72 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 26.736 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE (UNII: 92RU3N3Y1O) BEMOTRIZINOL (UNII: PWZ1720CBH) NIACINAMIDE (UNII: 25X51I8RD4) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) C14-22 ALCOHOLS (UNII: B1K89384RJ) TREHALOSE (UNII: B8WCK70T7I) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-100 STEARATE (UNII: YD01N1999R) DOCOSANOL (UNII: 9G1OE216XY) PHENOXYETHANOL (UNII: HIE492ZZ3T) C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) STEARIC ACID (UNII: 4ELV7Z65AP) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) XANTHAN GUM (UNII: TTV12P4NEE) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ADENOSINE (UNII: K72T3FS567) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FERRIC OXIDE RED (UNII: 1K09F3G675) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ZINC OXIDE (UNII: SOI2LOH54Z) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T) D&C RED NO. 33 (UNII: 9DBA0SBB0L) NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E) SAFFLOWER (UNII: 4VBL71TY4Y) CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF) PRUNUS MUME FLOWER (UNII: 2N8872050J) PYRUS COMMUNIS FLOWER (UNII: P6Y3X4TOIW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73016-004-02 1 in 1 CARTON 04/03/2019 1 NDC:73016-004-01 50 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/03/2019 Labeler - ACTIVEBEUTY CO.,LTD (695911007) Registrant - ACTIVEBEUTY CO.,LTD (695911007) Establishment Name Address ID/FEI Business Operations ACTIVEBEUTY CO.,LTD 695911007 manufacture(73016-004)
