Label: MACROANTIOXIDANT SUN PROTECTION- avobenzone, homosalate, octinoxate, octocrylene, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 63730-340-01 - Packager: Natura Bisse International SA
- 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 February 2, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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
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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)