EVERYDAY FACIAL MOISTURIZER AND SUNSCREEN SPF 20- zinc oxide cream

Everyday Facial Moisturizer And Sunscreen SPF 20 by

Drug Labeling and Warnings

Everyday Facial Moisturizer And Sunscreen SPF 20 by is a Otc medication manufactured, distributed, or labeled by 714 Essentials LTD, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/09/2011

Labeler - 714 Essentials LTD (829052146)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(76230-727)

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