NDC | 63730-364-01 |
Set ID | 0bb64b29-b587-450a-a703-9446e9fc618a |
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 4% ...................................................................... Sunscreen
Octocrylene 10% ................................................................... Sunscreen
Oxybenzone 5% .................................................................... 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. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sun-glasses.
- WARNINGS
-
INACTIVE INGREDIENT
Inactive Ingredients
alcohol denat., diisopropyl sebacate, benzotriazolyl dodecyl p-cresol, tocopheryl acetate, glyceryl linoleate, vitis vinifera (grape) seed oil, bisabolol, helianthus annuus (sunflower) seed oil, citrus nobilis (mandarin orange) oil, glyceryl linolenate, daucus carotiva sativa (carrot) seed oil, beta-carotene, 7-dehydrocholesterol, ascorbyl palmitate, acrylates/octylacrylamide copolymer, fragrance, limonene, linalool, amyl cinnamal, geraniol, citral.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DRY OIL ANTIOXIDANT SUN PROTECTION
avobenzone, homosalate, octinoxate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63730-364 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 4 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL LINOLEATE (UNII: 4763AXI84L) GRAPE SEED OIL (UNII: 930MLC8XGG) LEVOMENOL (UNII: 24WE03BX2T) HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR) CITRUS NOBILIS (UNII: 8MFF77J91V) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) GLYCERYL LINOLENATE (UNII: SGB6X4G86K) DAUCUS CAROTA SUBSP. SATIVUS WHOLE (UNII: F9I9HZH3O3) BETA CAROTENE (UNII: 01YAE03M7J) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) ASCORBYL PALMITATE (UNII: QN83US2B0N) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+)- (UNII: F4VNO44C09) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) GERANIOL (UNII: L837108USY) CITRAL (UNII: T7EU0O9VPP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63730-364-01 100 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/30/2015 Labeler - Natura Bisse International SA (464431576) Establishment Name Address ID/FEI Business Operations Natura Bisse International SA 464431576 manufacture(63730-364)