ACTIBEAU CAMELLIA FLORAL CALMING SUNSCREEN- octinoxate, titanium dioxide cream

ACTIBEAU Camellia Floral Calming Sunscreen by

Drug Labeling and Warnings

ACTIBEAU Camellia Floral Calming Sunscreen by is a Otc medication manufactured, distributed, or labeled by ACTIVEBEUTY CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 7.2%
Titanium Dioxide 4.8184%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

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

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 using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

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

INGREDIENTS AND APPEARANCE

ACTIBEAU CAMELLIA FLORAL CALMING SUNSCREEN 
octinoxate, titanium dioxide cream

Product 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)