3LAB AQUA BB SPF 40 BROAD SPECTRUM 01- titanium dioxide cream

3LAB Aqua BB SPF 40 BROAD SPECTRUM 01 by

Drug Labeling and Warnings

3LAB Aqua BB SPF 40 BROAD SPECTRUM 01 by is a Otc medication manufactured, distributed, or labeled by 3LAB, Inc., Englewood Lab, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

3LAB Aqua BB SPF 40 BROAD SPECTRUM #01

Active Ingredient

Titanium Dioxide 7.86%

Purpose

Sunscreen

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply
  - After 40 minutes of swimming or sweating
  - Immediately after towel drying
  - At least every 2 hours
• 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 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-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months : Ask a doctor
  

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Cyclopentasiloxane, Rosa Centifolia Flower Water, Water (Aqua/Eau), Butylene Glycol, Butyloctyl Salicylate, PEG-10 Dimethicone, Trimethylsiloxysilicate, Lactobacillus Fermentum, Dimethicone, Sodium PCA, Glycerin, Alumina, Trisiloxane, Glycereth-26, Sodium Hyaluronate, Adenosine, Dimethicone/PEG-10/15 Crosspolymer, Alteromonas Ferment Extract, Dipotassium Glycyrrhizate, Allantoin, Beta-Glucan, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Tocopheryl Acetate, Carbomer, Methicone, PEG/PPG-20/15 Dimethicone, Triethoxycaprylylsilane, Hydrolyzed Wheat Protein/PVP Crosspolymer, Polysorbate 20, 1,2-Hexanediol, Caprylyl Glycol, Disodium EDTA, Phenoxyethanol, Citrus Aurantium Dulcis Oil, Lavandula Angustifolia (Lavender) Oil
May contain:
Titanium Dioxide, Iron Oxides (C.I. 77491), Iron Oxides (C.I. 77492), Iron Oxides (C.I. 77499)

3LAB Aqua BB SPF 40 BROAD SPECTRUM #01 28ml (

76159-004-00)

INGREDIENTS AND APPEARANCE

3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76159-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRISILOXANE (UNII: 9G1ZW13R0G)
GLYCERETH-26 (UNII: NNE56F2N14)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ADENOSINE (UNII: K72T3FS567)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ALLANTOIN (UNII: 344S277G0Z)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAVENDER OIL (UNII: ZBP1YXW0H8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76159-004-00	1 in 1 CARTON	12/19/2017
1		28 mL in 1 JAR; 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	11/18/2013

Labeler - 3LAB, Inc. (162333277)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc		080366903	manufacture(76159-004)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76159-004)