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NDC 72330-0196-01 THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50 1.75; 3.5; 2.25; 2.285; 5.825 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL Details

THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50 1.75; 3.5; 2.25; 2.285; 5.825 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL

THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by fmg Co.Ltd. The primary component is ENSULIZOLE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	72330-0196
Product ID	72330-196_d30b156a-b9b8-499b-e053-2a95a90ada6a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ensulizole, Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	1.75; 3.5; 2.25; 2.285; 5.825
Active Ingredient Units	g/50mL; g/50mL; g/50mL; g/50mL; g/50mL
Substance Name	ENSULIZOLE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	fmg Co.Ltd
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72330-0196-01 (72330019601)

Pricing Information	N/A
NDC Package Code	72330-196-01
Billing NDC	72330019601
Package	2 TUBE in 1 BOX (72330-196-01) / 50 mL in 1 TUBE
Marketing Start Date	2018-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d30b183d-a54d-752c-e053-2a95a90a24fc Details

ACTIVE INGREDIENTS

Ensulizole 3.5%

Octinoxate 7.00%

Octisalate 4.5%

Titanium Dioxide 4.57%

Zinc Oxide 11.65%

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

SPL UNCLASSIFIED SECTION

Do not use on damaged or broken skin

SPL UNCLASSIFIED SECTION

When using this product keep out of eyes. Rinse with water to remove

SPL UNCLASSIFIED SECTION

Stop use and ask doctor if rash occurs

SPL UNCLASSIFIED SECTION

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 and as needed.
Reapply as needed or after towel drying, swimming, or sweating.
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 value of 15 or higher and other sun protection measures including:

- Limit time in the sun, especially from 10 a.m. to 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, PANTHENOL, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, STEARIC ACID, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, MICA, NYLON 12, ETHYLHEXYLGLYCERIN, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, TRISODIUM EDTA, HELIANTHUS ANNUS (SUNFLOWER) SRPOUT EXTRACT, MENTHYL PCA, SODIUM PCA, SODIUM BENZOATE, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), FRAGRANCE

OTHER INFORMATION

Protect this product from excessive heat and direct sun

QUESTIONS OR COMMENTS?

Call toll free 1-888-498-9004

PRINCIPAL DISPLAY PANEL NATURAL SUN LONG LASTING SUNSCREEN BROAD SPECTRUM SPF 50 1.69 fl. oz. 50 mL

INGREDIENTS AND APPEARANCE

THEFACESHOP NATURAL SUN LONG LASTING SUNSCREEN BROAD SPECTRUM SPF 50

ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72330-196
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.285 g in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.75 g in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.825 g in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
NYLON-12 (UNII: 446U8J075B)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
MENTHYL DL-PYRROLIDONECARBOXYLATE (UNII: 8P18J856U2)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
ZINC STEARATE (UNII: H92E6QA4FV)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TROMETHAMINE (UNII: 023C2WHX2V)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
EDETATE TRISODIUM (UNII: 420IP921MB)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72330-196-01	2 in 1 BOX	01/01/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2018

Labeler - fmg Co.Ltd (690188305)

Registrant - LG HOUSEHOLD & HEALTH CARE LTD (688276187)

Name	Address	ID/FEI	Business Operations
Establishment
fmg Co.Ltd		690188305	manufacture(72330-196)

Revised: 12/2021

Document Id: d30b156a-b9b8-499b-e053-2a95a90ada6a

Set id: d30b183d-a54d-752c-e053-2a95a90a24fc

Version: 1

Effective Time: 20211213

Search by Drug Name or NDC

NDC 72330-0196-01 THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50 1.75; 3.5; 2.25; 2.285; 5.825 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL Details

THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50 1.75; 3.5; 2.25; 2.285; 5.825 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL

Product Information

Package

Package Images

NDC 72330-0196-01 (72330019601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d30b183d-a54d-752c-e053-2a95a90a24fc Details

ACTIVE INGREDIENTS

PURPOSE

USES

WARNINGS

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

DIRECTIONS

INACTIVE INGREDIENTS

OTHER INFORMATION

QUESTIONS OR COMMENTS?

PRINCIPAL DISPLAY PANEL NATURAL SUN LONG LASTING SUNSCREEN BROAD SPECTRUM SPF 50 1.69 fl. oz. 50 mL

INGREDIENTS AND APPEARANCE

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