Label: YOUTH ACTIVATING BB SPF30 SHADE 3- zinc oxide, titanium dioxide cream
- NDC Code(s): 14268-025-30
- Packager: Englewood Lab, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2023
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- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENTS
- 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 bu the sun. To decrease the 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 Simming or sweating
- OTHER INFORMATION
- SPL UNCLASSIFIED SECTION
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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 (CI 77891), Iron Oxides (CI 77491), 77492, 77499)
- Package Labeling:
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INGREDIENTS AND APPEARANCE
YOUTH ACTIVATING BB SPF30 SHADE 3
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14268-025 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 WATER (UNII: 059QF0KO0R) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BABASSU OIL (UNII: 8QSB4M5477) MUSCADINE GRAPE (UNII: 072T3X480E) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) TRISILOXANE (UNII: 9G1ZW13R0G) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PANTOTHENIC ACID (UNII: 19F5HK2737) GRAPE (UNII: 6X543N684K) ASCORBIC ACID (UNII: PQ6CK8PD0R) LEVOMENOL (UNII: 24WE03BX2T) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) ISOSTEARIC ACID (UNII: X33R8U0062) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14268-025-30 1 in 1 CARTON 11/22/2017 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 Drug M020 11/22/2017 Labeler - Englewood Lab, Inc. (172198223) Establishment Name Address ID/FEI Business Operations Englewood Lab, Inc. 172198223 manufacture(14268-025)
