Label: BOTANIC TWENTY DAILY SUNBLOCK SPF50- octinoxate, titanium dioxide lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 71364-004-01, 71364-004-02 - Packager: RITZY NOBLE CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 1, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL BOTANIC TWENTY SPF50+ / PA+++ DAILY SUNBLOCK 50 ml
-
INGREDIENTS AND APPEARANCE
BOTANIC TWENTY DAILY SUNBLOCK SPF50
octinoxate, titanium dioxide lotionProduct 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)
