ISA KNOX 365 BB SUNSCREEN BROAD SPECTRUM SPF 40, PA- titanium dioxide cream

ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA by

Drug Labeling and Warnings

ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA by is a Otc medication manufactured, distributed, or labeled by LG Household and Healthcare, 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.
• Higher SPF gives more sunburn protection.
  

Warnings

For External use only.

Do not use

on irritated or broken skin.

Stop use and ask a physician

if rash, irritation or sensitivity develops and lasts.

When using product

do not get into eyes. If eye contact occurs, rinse eyes thoroughly with water.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally before exposure to the sun.
• Reapply after excessive perspiration or swimming.
• Ask a doctor before use on children under 3 years of age.
  

Other information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Inactive ingredients

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

ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA

Daily BB sunscreen is compatible with makeup base (SPF 40, PA+++). When used, it gives exceptional, long lasting, Broad Spectrum results. It forms a smooth, thin, and supple protective film on the skin that prevents the loss of moisture

Distributed by
LG Household and Health Care America
17777 Center Court Dr. Suite 650,
Cerritos, CA 90703, USA
Questions? 1-888-498-9004

Made in U.S.A.

PRINCIPAL DISPLAY PANEL

365 BB SUNSCREEN Broad Spectrum SPF 40, PA+++

ISA KNOX

NET WT. 1.7 OZ / 50 g

Product Label

INGREDIENTS AND APPEARANCE

ISA KNOX 365 BB SUNSCREEN BROAD SPECTRUM SPF 40, PA 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-000
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
GLYCERETH-26 (UNII: NNE56F2N14)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
SHEA BUTTER (UNII: K49155WL9Y)
ORANGE OIL (UNII: AKN3KSD11B)
CHAMOMILE (UNII: FGL3685T2X)
FENNEL SEED (UNII: G3QC02NIE6)
OLIVE OIL (UNII: 6UYK2W1W1E)
HOPS (UNII: 01G73H6H83)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SQUALANE (UNII: GW89575KF9)
CERAMIDE 3 (UNII: 4370DF050B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERIN (UNII: PDC6A3C0OX)
ADENOSINE (UNII: K72T3FS567)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ALLANTOIN (UNII: 344S277G0Z)
ALCOHOL (UNII: 3K9958V90M)
BORON NITRIDE (UNII: 2U4T60A6YD)
UREA (UNII: 8W8T17847W)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM OLEATE (UNII: 399SL044HN)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EDETIC ACID (UNII: 9G34HU7RV0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-000-00	1 in 1 PACKAGE	12/19/2017
1		50 g 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	03/13/2013

Labeler - LG Household and Healthcare, Inc. (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(53208-000)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(53208-000)