FDA.reportPublic FDA data

Everyday Facial Moisturizer And Sunscreen SPF 20

Manufacturer
714 Essentials LTD | Englewood Lab, Inc.
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:34:34

Label at a glance#

ProductEveryday Facial Moisturizer And Sunscreen SPF 20
Active ingredientZINC OXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT: Zinc Oxide 16.32%

Purpose

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

For external us only. Do not get into eyes.

OTC - STOP USE SECTION

Discontinue use if irritation or rash appears.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of childrens reach

DOSAGE & ADMINISTRATION SECTION

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

OTHER INGREDIENTS:

INACTIVE INGREDIENT SECTION

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 SECTION

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

PACKAGE LABEL.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

PACKAGE LABEL.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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ottilie Lulu1Ottilie Lulu1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ottilie Lulu2Ottilie Lulu2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130899837002093GTIN-13: 0899837002093
EAN-13: 0899837002093
GTIN-12: 899837002093
UPC-A: 899837002093
GTIN storage (14 digits): 00899837002093		OttilieLulu2.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76230-727-092026-01-23C16284748780-12cef2736-9f49-d83d-e063-dadaa90ab31fEveryday Facial Moisturizer And Sunscreen SPF 20
76230-727-092025-01-30C16284748780-12cef2736-9f49-d83d-e063-dadaa90ab31fEveryday Facial Moisturizer And Sunscreen SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76230-727-09Everyday Facial Moisturizer And Sunscreen SPF 2075 mL in 1 BOTTLECREAM757
76230-727-09Everyday Facial Moisturizer And Sunscreen SPF 201 in 1 PACKAGECREAM17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B01
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
ISONONYL ISONONANOATEINACTIVE INGREDIENTS4V5BS6GCX1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A21
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76230-72776230-727-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM CHLORIDE451W47IQ8XIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
PANTHENOLWV9CM0O67ZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
EDETATE DISODIUM7FLD91C86KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii+route
4 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii+route
4 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
6 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route
4 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
6 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Everyday Facial Moisturizer And Sunscreen SPF 20ZINC OXIDE714 Essentials LTD3a29018b-8103-4983-b0c5-5f340775a05d2023-12-12WarningsExact identifier
ndc (package): 76230-727-09
ndc (product): 76230-727
ndc11 (package): 76230072709
spl id: 0c5baaf8-ed77-5c24-e063-6394a90a9f3c
spl set id: 3a29018b-8103-4983-b0c5-5f340775a05d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.