BOTANIC TWENTY DAILY SUNBLOCK SPF50

Manufacturer
RITZY NOBLE CO., LTD. | B&B KOREA CO., LTD.
Effective date
2018-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:35

Label at a glance#

ProductBOTANIC TWENTY DAILY SUNBLOCK SPF50
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure13 sections

Indications and 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

Dosage and administration

• 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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 6.5%

TITANIUM DIOXIDE 3.53%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

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

STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call toll free 1-800-311-6680

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAILYDAILY

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71364-004-022020-01-31C16284748780-19d75b9cf-e90c-f424-e053-dadaa90a57ceBotanic Twenty Daily Sunblock SPF50+ / PA+++

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71364-004-01BOTANIC TWENTY DAILY SUNBLOCK SPF5050 mL in 1 TUBELOTION501
71364-004-02BOTANIC TWENTY DAILY SUNBLOCK SPF501 in 1 BOXLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71364-004BOTANIC TWENTY DAILY SUNBLOCK SPF50 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [RITZY NOBLE CO., LTD.]1Legacy NDC, 2 package rows20181212_7cb97fc9-59bf-3271-e053-2a91aa0afa5c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71364-00471364-004-01, 71364-004-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7cb97fc9-59c0-3271-e053-2a91aa0afa5c7cb97fc9-59bf-3271-e053-2a91aa0afa5c2018-01-01WarningsExact identifier
spl id: 7cb97fc9-59c0-3271-e053-2a91aa0afa5c
spl set id: 7cb97fc9-59bf-3271-e053-2a91aa0afa5c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.