YOUTH ACTIVATING BB SPF30 SHADE 3- zinc oxide, titanium dioxide cream

Youth Activating BB SPF30 Shade 3 by

Drug Labeling and Warnings

Youth Activating BB SPF30 Shade 3 by is a Otc medication manufactured, distributed, or labeled by Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

Zinc Oxide 6.30%

Titanium Dioxide 2.36%

PURPOSE

Sunscreen

USES

• Helps prevent sunburn

WARNINGS

• For external use only

Do not use 

• on damaged or broken skin

When using this product 

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

• Protect the product in this container from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

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:

INGREDIENTS AND APPEARANCE

YOUTH ACTIVATING BB SPF30 SHADE 3 
zinc oxide, titanium dioxide cream

Product 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 not final	part352	11/22/2017

Labeler - Englewood Lab, Inc. (080366903)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(14268-025)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(14268-025)