NDC | 63730-340-01 |
Set ID | 1b27d084-d9e3-442d-80bd-cc217fd20315 |
Category | HUMAN OTC DRUG LABEL |
Packager | Natura Bisse International SA |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 3% .................................................... Sunscreen
Homosalate 10% ................................................... Sunscreen
Octinoxate 7.5% .................................................... Sunscreen
Octocrylene 10% ................................................... Sunscreen
Oxybenzone 3% .................................................... Sunscreen
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: ask a doctor
- 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. - 2p.m.
- wear long-sleeved shirts, pants, hats, and sun-glasses.
- WARNINGS
-
INACTIVE INGREDIENT
Inactive Ingredients
water, alcohol denat., propanediol, glycerin, propylheptyl caprylate, glyceryl stearate, oryza sativa (rice) starch, PEG-100 stearate, benzotriazolyl dodecyl p-cresol, citrus sinensis (orange) peel extract, tocopheryl acetate, glyceryl linoleate, hydrolyzed collagen, bisabolol, citrus nobilis (mandarin orange) oil, citrus aurantium dulcis (orange) oil, glyceryl linolenate, 7-dehydrocholesterol, polyacrylate crosspolymer-11, disodium EDTA, glyceryl polyacrylate, ethylhexylglycerin, tricalcium phosphate, citric acid, phenoxyethanol, fragrance, limonene, linalool, amyl cinnamal, geraniol, yellow 5 (CI 19140), red 4 (CI 14700).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MACROANTIOXIDANT SUN PROTECTION
avobenzone, homosalate, octinoxate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63730-340 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) PEG-100 STEARATE (UNII: YD01N1999R) BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X) CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL LINOLEATE (UNII: 4763AXI84L) GELATIN (UNII: 2G86QN327L) LEVOMENOL (UNII: 24WE03BX2T) CITRUS NOBILIS (UNII: 8MFF77J91V) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) GLYCERYL LINOLENATE (UNII: SGB6X4G86K) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PHENOXYETHANOL (UNII: HIE492ZZ3T) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+)- (UNII: F4VNO44C09) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) GERANIOL (UNII: L837108USY) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63730-340-01 30 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/02/2015 Labeler - Natura Bisse International SA (464431576) Establishment Name Address ID/FEI Business Operations Natura Bisse International SA 464431576 manufacture(63730-340)