FDA.reportPublic FDA data

Image Skincare Prevention Plus Daily Hydrating Moisturizer

Manufacturer
Natural Technology, LLC
Effective date
2022-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:53

Label at a glance#

ProductImage Skincare Prevention Plus Daily Hydrating Moisturizer
Active ingredientZINC OXIDE
Label structure12 sections

Dosage and administration

91g. NDC: 79458-001-01

Label contents#

Full prescribing information#

Zinc Oxide 17.1%. Purpose: Sunscreen

OTC - ACTIVE INGREDIENT SECTION

PP 91g - Active IngredientsPP 91g - Active Ingredients

91g. NDC: 79458-001-01

Purpose: Sunscreen

OTC - PURPOSE SECTION

PP 91g - PurposePP 91g - Purpose

91 g. NDC: 79458-001-01

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

INDICATIONS & USAGE SECTION

PP 91g - InstructionsPP 91g - Instructions

91g. NDC: 79458-001-01

For external use only

WARNINGS SECTION

PP 91g - WarningsPP 91g - Warnings

91 g. NDC: 79458-001-01

Do not use on damaged or broken skin.

PRECAUTIONS SECTION

PP 91g - PrecautionsPP 91g - Precautions91 g. NDC: 79458-000-06

When using this product keep out of eyes. Rinse with water to remove.

OTC - WHEN USING SECTION

PP 91g - When UsingPP 91g - When Using

91g. NDC: 79458-001-01

Stop use and ask a doctor if rash occurs.

OTC - ASK DOCTOR SECTION

PP 91g - Ask DoctorPP 91g - Ask Doctor

91g. NDC: 79458-001-01

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

PP 91g - Keep Out of Reach of ChildrenPP 91g - Keep Out of Reach of Children

91g. NDC:79458-001-01

Apply generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating: Immediately after towel drying. At least every 2 hours. Sun Protection Me...

DOSAGE & ADMINISTRATION SECTION

PP 91g - IndicationsPP 91g - Indications

91g. NDC: 79458-001-01

Protect the product in this container from excessive heat and direct sun

OTHER SAFETY INFORMATION

PP 170g - Other Safety InfoPP 170g - Other Safety Info

91g. NDC: 79458-001-01

Aloe Barbadensis Leaf Juice, Cyclopentasiloxane, Dicaprylyl Carbonate, Glycerin, Aqua/Water/Eau, Alcohol Denat. (SD Alcohol 40-B), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Hydrated Silica, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethi...

INACTIVE INGREDIENT SECTION

PP 91g - Inactive IngredientsPP 91g - Inactive Ingredients

91g. NDC: 79458-001-01

Prevention plus daily hydrating moisturizer 30 SPF/FPS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PP91g - PrincipalPP91g - Principal91g. NDC: 79458-001-01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79458-001-022024-01-30C16284748780-11030e365-0928-111a-e063-dadaa90a10e2d5c9b709-cef0-3685-e053-2995a90a6fec

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79458-001-01Image Skincare Prevention Plus Daily Hydrating Moisturizer91 g in 1 TUBECREAM911
79458-001-02Image Skincare Prevention Plus Daily Hydrating Moisturizer1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79458-001IMAGE SKINCARE PREVENTION PLUS DAILY HYDRATING MOISTURIZER (ZINC OXIDE) CREAM [NATURAL TECHNOLOGY, LLC]1Legacy NDC, 2 package rows20220323_d5c9b709-cef0-3685-e053-2995a90a6fec.zip

Products#

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

DailyMed product names page 1 of 2 · 52 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79458-00179458-001-01, 79458-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 51 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCOCCUS LUTEUSLV6L29Z6AXIACT
ANACYSTIS NIDULANS EXTRACTUV4FTL6UAWIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
PROPANEDIOL5965N8W85TIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
APPLEB423VGH5S9IACT
ERYTHRITOLRA96B954X6IACT
SODIUM BENZOATEOJ245FE5EUIACT
HOMARINE HYDROCHLORIDE8866LNG61NIACT
SODIUM SUCCINATE HEXAHYDRATEU16QOD6C4EIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
ISOHEXADECANE918X1OUF1EIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
HYDRATED SILICAY6O7T4G8P9IACT
DIMETHICONE92RU3N3Y1OIACT
ARABIDOPSIS THALIANAAI3L60HQ81IACT
CITRUS MAXIMA FRUIT RIND5NX3G75CA6IACT
TANGERINE PEELJU3D414057IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PEA PROTEIN7Q50F46595IACT
ALOE VERA LEAFZY81Z83H0XIACT
ORANGE PEELTI9T76XD44IACT
TOCOPHEROLR0ZB2556P8IACT
BABASSU SEEDHL2549X1EYIACT
LYCIUM CHINENSE FRUITTG711Q7A1QIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CITRALT7EU0O9VPPIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT

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
d5c9b709-cef1-3685-e053-2995a90a6fecd5c9b709-cef0-3685-e053-2995a90a6fec2022-03-17WarningsExact identifier
spl id: d5c9b709-cef1-3685-e053-2995a90a6fec
spl set id: d5c9b709-cef0-3685-e053-2995a90a6fec

Reported adverse events (FAERS/openFDA)#

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