ACTIBEAU CAMELLIA FLORAL CALMING SUNSCREEN- octinoxate, titanium dioxide cream 
ACTIVEBEUTY 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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73016-004

Octinoxate 7.2%
Titanium Dioxide 4.8184%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

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 using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

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

image description

ACTIBEAU CAMELLIA FLORAL CALMING SUNSCREEN 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73016-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE72 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE26.736 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73016-004-021 in 1 CARTON04/03/2019
1NDC:73016-004-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/03/2019
Labeler - ACTIVEBEUTY CO.,LTD (695911007)
Registrant - ACTIVEBEUTY CO.,LTD (695911007)
Establishment
NameAddressID/FEIBusiness Operations
ACTIVEBEUTY CO.,LTD695911007manufacture(73016-004)

Revised: 4/2019
Document Id: 85a9522e-a700-bd04-e053-2a91aa0a61f3
Set id: 61fabd61-c3f8-4045-a83d-3192bb2cb41a
Version: 1
Effective Time: 20190403
 
ACTIVEBEUTY CO.,LTD