Your browser does not support JavaScript! 3LAB PERFECT BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC]
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3LAB PERFECT BB SPF 40 BROAD SPECTRUM 01 (titanium dioxide) cream
[3LAB, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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.

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

Product Label

Perfect BB 1

3LAB PERFECT BB SPF 40 BROAD SPECTRUM 01 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76159-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE121.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
BUTYLENE GLYCOL 
ALUMINUM STARCH OCTENYLSUCCINATE 
ASCORBYL GLUCOSIDE 
CAPRYLYL TRISILOXANE 
GLYCERETH-26 
NEOPENTYL GLYCOL DICAPRATE 
PHENYL TRIMETHICONE 
DIMETHICONE 
ALUMINUM OXIDE 
DIPROPYLENE GLYCOL 
SODIUM CHLORIDE 
SQUALANE 
ACHILLEA MILLEFOLIUM 
SHEA BUTTER 
CHAMOMILE 
FENNEL SEED 
HOPS 
MELISSA OFFICINALIS LEAF 
VISCUM ALBUM FRUITING TOP 
OLIVE OIL 
.ALPHA.-TOCOPHEROL ACETATE 
ADENOSINE 
TOCOPHEROL 
HYALURONATE SODIUM 
ALLANTOIN 
CERAMIDE 3 
GLYCERIN 
PEG/PPG-20/15 DIMETHICONE 
PEG/PPG-18/18 DIMETHICONE 
SILICON DIOXIDE 
SODIUM OLEATE 
SODIUM PYRROLIDONE CARBOXYLATE 
TRIETHOXYCAPRYLYLSILANE 
UREA 
XANTHAN GUM 
PANTHENOL 
POTASSIUM HYDROXIDE 
GLYCYRRHIZINATE DIPOTASSIUM 
SODIUM PHOSPHATE 
CAPRYLYL GLYCOL 
BORON NITRIDE 
ALCOHOL 
EDETATE DISODIUM 
EDETIC ACID 
PHENOXYETHANOL 
ORANGE OIL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76159-001-001 in 1 CARTON
145 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/10/2013
Labeler - 3LAB, Inc (162333277)
Establishment
NameAddressID/FEIBusiness Operations
Englewood Lab, LLC172198223manufacture(76159-001)

Revised: 1/2013
 
3LAB, Inc

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