BOTANIC TWENTY DAILY SUNBLOCK SPF50- octinoxate, titanium dioxide lotion

BOTANIC TWENTY DAILY SUNBLOCK SPF50 by

Drug Labeling and Warnings

BOTANIC TWENTY DAILY SUNBLOCK SPF50 by is a Otc medication manufactured, distributed, or labeled by RITZY NOBLE CO., LTD., B&B KOREA CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

OCTINOXATE 6.5%

TITANIUM DIOXIDE 3.53%

PURPOSE

Sunscreen

USES

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

For external use only

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply liberally 15 minutes before sun exposure and as needed.
Reapply as needed or after towel drying, swimming, or sweating.
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer
and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad
Spectrum SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. to 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

WATER, BUTYLENE GLYCOL, SEA WATER, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, STEARYL HEPTANOATE, C12-15 ALKYL BENZOATE, ISOAMYL P-METHOXYCINNAMATE, CETEARYL ALCOHOL, 1,2-HEXANEDIOL, POLYSORBATE 60, GLYCERYL STEARATE, NIACINAMIDE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CHRYSANTHELLUM INDICUM EXTRACT, CHAMAECYPARIS OBTUSA LEAF EXTRACT, COPTIS JAPONICA ROOT EXTRACT, CORYDALIS TURTSCHANINOVII ROOT EXTRACT, HOUTTUYNIA CORDATA EXTRACT, ILLICIUM VERUM (ANISE) FRUIT EXTRACT, LARIX SIBIRICA WOOD EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, RHEUM PALMATUM ROOT/STALK EXTRACT, STEARYL CAPRYLATE, BEESWAX, POLYMETHYL METHACRYLATE, SORBITAN SESQUIOLEATE, POLYMETHYLSILSESQUIOXANE, PEG-100 STEARATE, OLETH-10, BETAINE, STEARIC ACID, MAGNESIUM ALUMINUM SILICATE, ALUMINUM HYDROXIDE, ORYZA SATIVA (RICE) EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, BRASSICA OLERACEA BOTRYTIS (CAULIFLOWER) EXTRACT, LILIUM CANDIDUM FLOWER EXTRACT, MAGNOLIA LILIFLORA FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, PUNICA GRANATUM FRUIT EXTRACT, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, ALLANTOIN, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, ADENOSINE, EUCALYPTUS GLOBULUS LEAF OIL, SILICA, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, LAVANDULA HYBRIDA OIL, CAPRYLHYDROXAMIC ACID, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, CITRUS AURANTIFOLIA (LIME) OIL, XANTHAN GUM, MORINGA PTERYGOSPERMA SEED EXTRACT, LEPIDIUM MEYENII ROOT EXTRACT, ASPARAGUS COCHINCHINENSIS ROOT EXTRACT, AUREOBASIDIUM PULLULANS FERMENT, ARTEMISIA ANNUA EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, SACCHAROMYCES FERMENT, CENTELLA ASIATICA EXTRACT, POLYGONUM CUSPIDATUM ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

QUESTIONS OR COMMENTS?

Call toll free 1-800-311-6680

PRINCIPAL DISPLAY PANEL BOTANIC TWENTY SPF50+ / PA+++ DAILY SUNBLOCK 50 ml

INGREDIENTS AND APPEARANCE

BOTANIC TWENTY DAILY SUNBLOCK SPF50 
octinoxate, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71364-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.25 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.765 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
AMILOXATE (UNII: 376KTP06K8)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CHRYSANTHELLUM INDICUM WHOLE (UNII: YPX537PA31)
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
STAR ANISE FRUIT (UNII: CK15HA8438)
STEARYL CAPRYLATE (UNII: 06TS6O9194)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYSORBATE 60 (UNII: CAL22UVI4M)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)
NIACINAMIDE (UNII: 25X51I8RD4)
COPTIS JAPONICA ROOT (UNII: JH0SWT16D1)
LARIX SIBIRICA WOOD (UNII: KSC3PGF73L)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
RHEUM PALMATUM ROOT (UNII: G025DAL7CE)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CORYDALIS TURTSCHANINOVII WHOLE (UNII: I94Q8D25FS)
HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71364-004-02	1 in 1 BOX	01/01/2018
1	NDC: 71364-004-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2018

Labeler - RITZY NOBLE CO., LTD. (690425290)

Establishment
Name	Address	ID/FEI	Business Operations
B&B KOREA CO., LTD.		688499349	manufacture(71364-004)

Establishment
Name	Address	ID/FEI	Business Operations
RITZY NOBLE CO., LTD.		690425290	label(71364-004)