NDC | 59899-012-01 |
Set ID | ccc80ea4-f270-4fd4-970c-eaa63df936e4 |
Category | HUMAN OTC DRUG LABEL |
Packager | Shaklee Corporation |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- DRUG FACTS
- ACTIVE INGREDIENT
- USES
- WARNINGS
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DIRECTIONS
- Apply generously 15 minutes before sun exposure
- Children under 6 months of age: Ask a doctor
- Sun Protection Measures. Spending time in the sun increases the risk of skin cancer and early skin aging caused by the sun. 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 sunglasses
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if swimming or sweating
- OTHER INFORMATION
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INACTIVE INGREDIENTS
Water, Argania Spinosa (Argan) Kernel Oil, Tocopheryl Acetate (Vitamin E), Caprylic/Capric Triglyceride (Fractionated Coconut Oil), Silica,
Orbignya Oleifera (Moringa Tree) Seed Oil, Vitis Rotundifolia (Muscadine Grape) Fruit Extract, Enteromorpha Compressa (Green Algae) Extract, Phenyl Trimethicone, Propanediol, Dimethicone, Butyloctyl Salicylate, Glycerin, Polyhydroxystearic Acid, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/ Sebacate, Polyglyceryl-2 Oleate, Trisiloxane, Magnesium Sulfate, Alteromonas Ferment Extract, Panthenol (Vitamin B5), Vitis Vinifera (Grape) Seed Extract, Magnesium Ascorbyl Phosphate (Vitamin C), Bisabolol, Caesalpinia Spinosa (Tara Tree) Gum, Phenoxyethanol, Butylene Glycol, Polyglyceryl-2 Stearate, Isostearic Acid, Sucrose Dilaurate, Lecithin, Polyglyceryl-3 Polyricinoleate, Disteardimonium Hectorite, Triethoxycaprylylsilane, Cetearyl Dimethicone Crosspolymer, Alumina, Sodium Cocoyl Glutamate, Stearic Acid, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Dimethicone/Vinyl Dimethicone Crosspolymer, Superoxide Dismutase, 1,2-Hexanediol, Beta-Glucan, Caprylyl Glycol, Pisum Sativum (Pea) Extract May Contain Titanium Dioxide (C.I. 77891), Iron Oxides (C.I. 77491, 77492, 77499) - Package Labeling:
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INGREDIENTS AND APPEARANCE
YOUTH 3 ACTIVATING BB CREAM SPF 30 MEDIUM
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59899-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 63 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 23.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) TRISILOXANE (UNII: 9G1ZW13R0G) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PANTHENOL (UNII: WV9CM0O67Z) VITIS VINIFERA SEED (UNII: C34U15ICXA) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) LEVOMENOL (UNII: 24WE03BX2T) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) SUCROSE DILAURATE (UNII: 5926LC4S7M) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PEA (UNII: W4X7H8GYFM) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) WATER (UNII: 059QF0KO0R) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BABASSU OIL (UNII: 8QSB4M5477) MUSCADINE GRAPE (UNII: 072T3X480E) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59899-012-01 1 in 1 CARTON 08/09/2017 1 30 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 not final part352 08/09/2017 Labeler - Shaklee Corporation (020284076)