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

3LAB PERFECT BB SPF 40 Broad Spectrum 01 by

Drug Labeling and Warnings

3LAB PERFECT 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]

Drug Facts

Active Ingredients

Titanium Dioxide 12.16%

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

Water (Aqua/Eau),Cyclopentasiloxane, Butylene Glycol, Aluminum Starch Octenylsuccinate, Cetyl PEG/PPG-10/1Dimethicone, PEG-10 Dimethicone, Ascorbyl Glucoside, Caprylyl Methicone, Glycereth-26, Neopentyl Glycol Dicaprate, Phenyl Trimethicone, Dimethicone, Alumina, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol,Sodium Chloride, Disteardimonium Hectorite, Squalane, Achillea Millefolium Extract, Butyrospermum Parkii (Shea Butter), Chamomilla Recutita (Matricaria) Flower Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Humulus Lupulus (Hops) Extract, Malus Domestica Fruit Cell Culture, Melissa Officinalis Leaf Extract, Viscum Album (Mistletoe) Leaf Extract, Olea Europaea (Olive) Fruit Oil, Hydrolyzed Pea Protein, Tocopheryl Acetate, Adenosine, Oligopeptide-68, Rh-Polypeptide-7, Tocopherol, Sodium Hyaluronate, Allantoin, Beta-Glucan, Ceramide 3, Glycerin, Hydrogenated Lecithin, Lecithin, Methicone, Hydroxyethylcellulose, PEG/PPG-20/15 Dimethicone, PEG/PPG-18/18 Dimethicone, Phytosterols, Silica, Sodium Oleate, Sodium PCA, Hydrolyzed Wheat Protein/PVP Crosspolymer, Triethoxycaprylylsilane, Urea, Xanthan Gum, Panthenol, Potassium Hydroxide, Dipotassium Glycyrrhizate, Sodium Phosphate, Caprylyl Glycol, Boron Nitride, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Alcohol, Disodium EDTA, EDTA, Phenoxyethanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Fragrance May contain:
Iron Oxides (C.I. 77491) Iron Oxides (C.I. 77492) Iron Oxides (C.I. 77499)

PERFECT BB SPF 40/PA+++

Infused with 3LAB’s signature bioengineered growth hormone and apple stem cell technology, PERFECT BB SPF 40 is a sheer tinted moisturizer designed to firm and lift the skin, regenerate new skin cells, brighten, moisturize, and protect.

Directions Apply to cleansed skin.

BIORIUS sprl,2 rue René Descartes,B-7000 Mons, Belgium Distributed by 3LAB,® Inc., Englewood, NJ 07631, U.S.A. www.3LAB.com / Made in U.S.A.

PRINCIPAL DISPLAY PANEL

3LAB  PERFECT BB SPF 40  BROAD SPECTRUM  #01 NET WT. 1.5 OZ. 45 mL e

Product Label

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76159-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	121.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
PANTHENOL (UNII: WV9CM0O67Z)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SODIUM PHOSPHATE (UNII: SE337SVY37)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BORON NITRIDE (UNII: 2U4T60A6YD)
ALCOHOL (UNII: 3K9958V90M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EDETIC ACID (UNII: 9G34HU7RV0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ORANGE OIL (UNII: AKN3KSD11B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERETH-26 (UNII: NNE56F2N14)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SQUALANE (UNII: GW89575KF9)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
SHEA BUTTER (UNII: K49155WL9Y)
CHAMOMILE (UNII: FGL3685T2X)
FENNEL SEED (UNII: G3QC02NIE6)
HOPS (UNII: 01G73H6H83)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)
OLIVE OIL (UNII: 6UYK2W1W1E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ADENOSINE (UNII: K72T3FS567)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
CERAMIDE 3 (UNII: 4370DF050B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM OLEATE (UNII: 399SL044HN)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
UREA (UNII: 8W8T17847W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76159-001-00	1 in 1 CARTON	12/19/2017
1		45 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 final	part352	01/10/2013

Labeler - 3LAB, Inc (162333277)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(76159-001)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76159-001)