ACTIBEAU CAMELLIA NATURAL MINERAL UV DEFENSE SUNSCREEN- zinc oxide, titanium dioxide cream

ACTIBEAU Camellia Natural Mineral UV Defense Sunscreen by

Drug Labeling and Warnings

ACTIBEAU Camellia Natural Mineral UV Defense 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

Zinc Oxide 10.952%
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, CYCLOPENTASILOXANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYLENE GLYCOL, ETHYLHEXYL PALMITATE, COCOS NUCIFERA (COCONUT) OIL, CETYL PEG/PPG-10/1 DIMETHICONE, DICAPRYLYL CARBONATE, NIACINAMIDE, ISOPROPYL MYRISTATE, GLYCERIN, 1,2-HEXANEDIOL, SODIUM CHLORIDE, CAPRYLYL METHICONE, QUATERNIUM-18 HECTORITE, EUPHORBIA CERIFERA (CANDELILLA) WAX, DIMETHICONE CROSSPOLYMER, ALUMINUM HYDROXIDE, BORON NITRIDE, PENTAERYTHRITYL TETRAETHYLHEXANOATE, SORBITAN ISOSTEARATE, POLYHYDROXYSTEARIC ACID, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, COCO-CAPRYLATE/CAPRATE, FRAGRANCE, DIMETHICONE, C12-15 ALKYL BENZOATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PROPYLENE CARBONATE, FERRIC OXIDE YELLOW (CI 77492), NEOPENTYL GLYCOL DIETHYLHEXANOATE, TOCOPHERYL ACETATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ADENOSINE, FERRIC OXIDE RED (CI 77491), DISODIUM EDTA, 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 NATURAL MINERAL UV DEFENSE SUNSCREEN 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73016-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	109.52 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	48.187 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
COCONUT OIL (UNII: Q9L0O73W7L)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
NIACINAMIDE (UNII: 25X51I8RD4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
QUATERNIUM-18 HECTORITE (UNII: IIS3YBV1XX)
CANDELILLA WAX (UNII: WL0328HX19)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BORON NITRIDE (UNII: 2U4T60A6YD)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ADENOSINE (UNII: K72T3FS567)
FERRIC OXIDE RED (UNII: 1K09F3G675)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
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: 73016-003-02	1 in 1 CARTON	04/03/2019
1	NDC: 73016-003-01	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(73016-003)