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DRUG FACTS
Botanic Twenty Daily Sunblock Spf50
FDA Label NDC 71364-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ritzy Noble Co., Ltd. for the product Botanic Twenty Daily Sunblock Spf50 (NDC 71364-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - when using, stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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
Otc - 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.
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