ACTIBEAU CAMELLIA FLORAL CALMING SUNSCREEN- octinoxate, titanium dioxide cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
ACTIVEBEUTY CO.,LTD
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen Helps prevent sunburn
Authorization status:
OTC monograph not final
Authorization number:
73016-004-01, 73016-004-02

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.

----------

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

ACTIBEAU CAMELLIA FLORAL CALMING SUNSCREEN

octinoxate, titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 16 -0 0 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

72 mg in 1 mL

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

26 .736 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

BEMO TRIZINO L (UNII: PWZ1720 CBH)

NIACINAMIDE (UNII: 25X51I8 RD4)

DIETHYLAMINO HYDRO XYBENZO YL HEXYL BENZO ATE (UNII: ANQ8 70 JD20 )

PO LY( METHYL METHACRYLATE; 4 50 0 0 0 MW) (UNII: Z47NNT4J11)

HYDRO GENATED PO LY( C6 -14 O LEFIN; 2 CST) (UNII: P0 TX0 8 39 8 7)

PO TASSIUM CETYL PHO SPHATE (UNII: 0 3KCY6 P7UT)

C14 -2 2 ALCO HO LS (UNII: B1K8 9 38 4RJ)

TREHALO SE (UNII: B8 WCK70 T7I)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

DO CO SANO L (UNII: 9 G1OE216 XY)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

C12 -2 0 ALKYL GLUCO SIDE (UNII: K6 7N5Z1RUA)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

AMMO NIUM ACRYLO YLDIMETHYLTAURATE/VP CO PO LYMER (UNII: W59 H9 29 6 ZG)

PO LYHYDRO XYSTEARIC ACID ( 2 3 0 0 MW) (UNII: YXH47AOU0 F)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

XANTHAN GUM (UNII: TTV12P4NEE)

NEO PENTYL GLYCO L DIETHYLHEXANO ATE (UNII: U6 8 ZV6 W6 2C)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

ADENO SINE (UNII: K72T3FS56 7)

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

ACTIVEBEUTY CO.,LTD

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

ZINC O XIDE (UNII: SOI2LOH54Z)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

CAMELLIA JAPO NICA SEED O IL (UNII: U37N0 S9 10 T)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

NELUMBO NUCIFERA FLO WER (UNII: 6 1W322NLDV)

LO NICERA JAPO NICA FLO WER (UNII: 446 5L2WS4Y)

STYPHNO LO BIUM JAPO NICUM FLO WER (UNII: 6 44C3CSB6 E)

SAFFLO WER (UNII: 4VBL71TY4Y)

CAMELLIA JAPO NICA FLO WER (UNII: KUB8 10 1TNF)

PRUNUS MUME FLO WER (UNII: 2N8 8 720 50 J)

PYRUS CO MMUNIS FLO WER (UNII: P6 Y3X4TOIW)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:730 16 -0 0 4-

1 in 1 CARTON

0 4/0 3/20 19

1

NDC:730 16 -0 0 4-0 1

50 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 4/0 3/20 19

Labeler -

ACT IVEBEUT Y CO.,LT D (695911007)

Registrant -

ACT IVEBEUT Y CO.,LT D (695911007)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ACTIVEBEUTY CO.,LTD

6 9 59 110 0 7

ma nufa c ture (730 16 -0 0 4)

Revised: 4/2019

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