FDA.reportPublic FDA data

Enfanti Derma Series 100% Mineral Sun Shield

Manufacturer
Orange Lab | Orange Lab, Inc.
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:06

Label at a glance#

ProductEnfanti Derma Series 100% Mineral Sun Shield
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 sections

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Purpose

OTC - PURPOSE SECTION

PurposePurpose

Uses

OTC - WHEN USING SECTION

UsesUses

Do not use / Warnings

OTC - DO NOT USE SECTION

Warning and Do not useWarning and Do not use

Directions :

INSTRUCTIONS FOR USE SECTION

DirectionsDirections

Sun Protection Measures

OTHER SAFETY INFORMATION

Sun Protection MeasuresSun Protection Measures

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out or reach of childrenKeep out or reach of children

Inactie ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Other information - Safety Sotarge, etc.

OTHER SAFETY INFORMATION

Other infoOther info

Package front display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label frontLabel front

Outer box artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

outer boxouter box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71331-110-022025-01-30C16284748780-12cef2736-8022-d83d-e063-dadaa90ab31fEnfanti Derma Series SPF 50 PA++++ 1.8 fl oz.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71331-110-01Enfanti Derma Series 100% Mineral Sun Shield60 g in 1 TUBECREAM602
71331-110-02Enfanti Derma Series 100% Mineral Sun Shield1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71331-110ENFANTI DERMA SERIES 100% MINERAL SUN SHIELD (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [ORANGE LAB]2Legacy NDC, 2 package rows20230111_d44d42af-cd23-7058-e053-2995a90ad66e.zip

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71331-11071331-110-01, 71331-110-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FERRIC OXIDE RED1K09F3G675IACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
ALLANTOIN344S277G0ZIACT
ROSEMARYIJ67X351P9IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CYCLOMETHICONE 50THT5PCI0RIACT
SYMPHYTUM OFFICINALE WHOLEH8FJJ6KX5YIACT
CHENOPODIUM QUINOA SEEDOO4K72NZ2XIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
MATRICARIA CHAMOMILLA LEAF6I9LN466F0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PROPYLENE CARBONATE8D08K3S51EIACT
EUTERPE OLERACEA WHOLEY57H6218HPIACT
PANAX GINSENG ROOT OILP9T4K47OM0IACT
ALUMINUM OXIDELMI26O6933IACT
EQUISETUM ARVENSE BRANCH1L0VKZ185EIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
SALVIA OFFICINALIS WHOLEM9C36LC10EIACT
PENTAERYTHRITYL TETRAISOSTEARATE9D7IK5483FIACT
URTICA DIOICA LEAFX6M0DRN46QIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHICONE 20H8YMB5QY0DIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
PROPANEDIOL5965N8W85TIACT
NIACINAMIDE25X51I8RD4IACT
COCONUT ALKANES1E5KJY107TIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
HYALURONATE SODIUMYSE9PPT4THIACT
ADENOSINEK72T3FS567IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT

Source Document#

Source XML

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
f1f09ca2-53e7-60e7-e053-2995a90aa2e3d44d42af-cd23-7058-e053-2995a90ad66e2023-01-10Exact identifier
spl id: f1f09ca2-53e7-60e7-e053-2995a90aa2e3
spl set id: d44d42af-cd23-7058-e053-2995a90ad66e

Reported adverse events (FAERS/openFDA)#

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