FDA.reportPublic FDA data

A24 Naturalism Sensitive Skin Sunscreen SPF 50

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

Label at a glance#

ProductA24 Naturalism Sensitive Skin Sunscreen SPF 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

active inactive in

Purpose

OTC - PURPOSE SECTION

Active/PurposeActive/Purpose

Uses

INDICATIONS & USAGE SECTION

UsesUses

Warnings

WARNINGS SECTION

WarningWarning

Directions

INSTRUCTIONS FOR USE SECTION

DireectionsDireections

Sun Protection Mesaures

OTHER SAFETY INFORMATION

Sun Protection MeasuresSun Protection Measures

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach childrenKeep out of reach children

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Other information - Safety storage, etc.

SAFE HANDLING WARNING SECTION

Other informationOther information

Questions or comments

OTC - QUESTIONS SECTION

questions or commentsquestions or comments

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube front displayTube front display

Package - outer box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package outer boxPackage outer 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
71331-109-022025-01-30C16284748780-12cef2736-99a5-d83d-e063-dadaa90ab31fA24 Naturalism Sensitive Skin Sunscreen SPF 50 PA++++

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71331-109-01A24 Naturalism Sensitive Skin Sunscreen SPF 5060 g in 1 TUBECREAM602
71331-109-02A24 Naturalism Sensitive Skin Sunscreen SPF 501 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71331-109A24 NATURALISM SENSITIVE SKIN SUNSCREEN SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [ORANGE LAB]2Legacy NDC, 2 package rows20230111_c68fa38a-8d89-67c4-e053-2995a90a769f.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
71331-10971331-109-01, 71331-109-02

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
ADENOSINEK72T3FS567IACT
PROPANEDIOL5965N8W85TIACT
ALOE VERA LEAFZY81Z83H0XIACT
NIACINAMIDE25X51I8RD4IACT
COCONUT ALKANES1E5KJY107TIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
ALUMINUM OXIDELMI26O6933IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
MATRICARIA CHAMOMILLA LEAF6I9LN466F0IACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISOSTEARIC ACIDX33R8U0062IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PROPYLENE CARBONATE8D08K3S51EIACT
CYCLOMETHICONE 50THT5PCI0RIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
EQUISETUM ARVENSE BRANCH1L0VKZ185EIACT
EUTERPE OLERACEA WHOLEY57H6218HPIACT
PANAX GINSENG ROOT OILP9T4K47OM0IACT
SYMPHYTUM OFFICINALE WHOLEH8FJJ6KX5YIACT
CHENOPODIUM QUINOA SEEDOO4K72NZ2XIACT
STEARIC ACID4ELV7Z65APIACT
HYALURONATE SODIUMYSE9PPT4THIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
CAPRYLYL GLYCOL00YIU5438UIACT
XANTHAN GUMTTV12P4NEEIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FERRIC OXIDE RED1K09F3G675IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
ROSEMARYIJ67X351P9IACT
SALVIA OFFICINALIS WHOLEM9C36LC10EIACT
PENTAERYTHRITYL TETRAISOSTEARATE9D7IK5483FIACT
URTICA DIOICA LEAFX6M0DRN46QIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT

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
f1f09ca2-53e5-60e7-e053-2995a90aa2e3c68fa38a-8d89-67c4-e053-2995a90a769f2023-01-10WarningsExact identifier
spl id: f1f09ca2-53e5-60e7-e053-2995a90aa2e3
spl set id: c68fa38a-8d89-67c4-e053-2995a90a769f

Reported adverse events (FAERS/openFDA)#

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