Everyday Facial Moisturizer And Sunscreen Spf 20 (Zinc Oxide) Cream [714 Essentials Ltd] -

EVERYDAY FACIAL MOISTURIZER AND SUNSCREEN SPF 20 (ZINC OXIDE) CREAM [714 ESSENTIALS LTD]
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NDC	76230-727-09
Set ID	3a29018b-8103-4983-b0c5-5f340775a05d
Category	HUMAN OTC DRUG LABEL
Packager	714 Essentials LTD
Generic Name
Product Class
Product Number
Application Number	PART352

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ACTIVE INGREDIENT

ACTIVE INGREDIENT: Zinc Oxide 16.32%
Purpose

Sunscreen
INDICATIONS & USAGE

USE: Provides broad spectrum protection against UVA (cause of cancer and aging) and UVB (sunburn) rays. Recommended for all skin types. Its powerful anti-inflammatory and antioxident properties (green tea, algae, and Vitamin E) guard against free radical damage. No ghostly residue. PABA free. Oil free.
WARNING:

For external us only. Do not get into eyes.
STOP USE

Discontinue use if irritation or rash appears.
DOSAGE & ADMINISTRATION

DIRECTIONS: Apply daily before sun exposure Re-apply after swimming.
OTHER INGREDIENTS:

Water, Cyclopentasiloxane, PEG-10 Dimethicone, Dimethicone, Butylene Glycol, Caprylyl Methicone, Isononyl Isononanoate, Dipropylene Glycol, Sodium Chloride, Hydrogenated Polyisobutene, Disteardimonium Hectorite, Dimethiconol, Sodium Hyaluronate, Sodium PCA, Algae Extract, Camellia Sinensis Leaf Extract, Dipotassium Glycyrrhizate, Panthenol, Tocopheryl Acetate, Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Fragrance.
DESCRIPTION

Ottilie and Lulu Non-Chemical Sunscreen Smooth Silky Feel Water-Resistant - Dermatologist Tested Allergy Tested - Clinically Tested Not Tested on Animals - Made in the USA Please Visit us at www.ottilieandlulu.com Manufactured exclusively for 714 Essentials LTD. Dba: Ottilie and Lulu'" NY. NY 10024
PRINCIPAL DISPLAY PANEL

Ottilie and Lulu Everyday Facial Moisturizer And Sunscreen SPF 20 Clean, Clear, Healthy Skin For Tweens 2.5 fl oz / 75 ml
PRINCIPAL DISPLAY PANEL

Please Visit us at www.ottilieandlulu.com Manufactured exclusively
for 714 Essentials LTD. Dba: Ottilie and Lulu'" NY. NY 10024 2.5 fl oz / 75 ml 8 99837 00209 3
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EVERYDAY FACIAL MOISTURIZER AND SUNSCREEN SPF 20
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76230-727
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	163.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PANTHENOL (UNII: WV9CM0O67Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76230-727-09	1 in 1 PACKAGE	12/19/2017
1		75 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/09/2011

Labeler - 714 Essentials LTD (829052146)

Name	Address	ID/FEI	Business Operations
Establishment
Englewood Lab, Inc.		080987545	manufacture(76230-727)

Name	Address	ID/FEI	Business Operations
Establishment
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76230-727)

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Medic

EVERYDAY FACIAL MOISTURIZER AND SUNSCREEN SPF 20 (ZINC OXIDE) CREAM [714 ESSENTIALS LTD]

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