FDA.reportPublic FDA data

Prevention Plus Daily Hydrating Moisturizer SPF 30

Manufacturer
Allure Labs Inc
Effective date
2019-12-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:11

Label at a glance#

ProductPrevention Plus Daily Hydrating Moisturizer SPF 30
Active ingredientZINC OXIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Zinc Oxide 21.0%

OTC - PURPOSE SECTION

Purpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses:

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

WARNINGS AND PRECAUTIONS SECTION

Warning: For external use only.

OTC - DO NOT USE SECTION

Do not use: on damaged or broken skin.

OTC - WHEN USING SECTION

When using this products:

  • Keep out of eyes.If contact occurs rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if :rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children:

  • If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions For Sunscreen Use:

  • 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. 
  •    Immediatly after towel drying. 
  •    at least every 2 hours.
  • Sun protection measures.Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  •  limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

Inactive ingredients: AQUA/WATER/EAU, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOPENTASILOXANE, GLYCERIN, BUTYLOCTYL SALICYLATE, DIMETHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, BUTYROSPERMUM PARKII NUT EXTRACT, STYRENE/ACRYLATES COPOLYMER, LECITHIN, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, CYCLOHEXASILOXANE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, POLYSILICONE-31, SORBITAN STEARATE, CETYL ALCOHOL, PHENOXYETHANOL, HEA/SODIUM ACRYOLYDIMETHYLTAURATE/STEARETH-20 METHACRYLATE COPOLYMER, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, HYDROLYZED JOJOBA ESTERS, LIMONENE, CAPRYLYL GLYCOL, ALLANTOIN, C13-14 ISOPARAFFIN, LAMINARIA DIGITATA EXTRACT, ARTEMISIA VULGARIS EXTRACT, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, XANTHAN GUM, BISABOLOL, POLYSORBATE 80, TOCOPHERYL ACETATE, CAMELLIA SINENSIS LEAF EXTRACT, DECYL GLUCOSIDE, ERYTHRITOL, SODIUM HYALURONATE, BIOSACCHARIDE GUM-1, VANILLA PLANIFOLIA FRUIT EXTRACT, GLUCOSE, HYDROLYZED PEA PROTEIN, PYRUVIC ACID, SODIUM CHLORIDE, BAROSMA BETULINA LEAF OIL, TETRAHEXYLDECYL ASCORBATE, POTASSIUM SORBATE, SODIUM BENZOATE, HOMARINE HCL, SODIUM SUCCINATE, ARABIDOPSIS THALIANA EXTRACT, MICROCOCCUS LYSATE, PLANKTON EXTRACT, ERGOTHIONEINE.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured for IMAGE Skincare, Lantana, FL 33462 USA

Manufactured in USA from globally sourced ingredients and components

www.ImageSkincare.com

Prevention Plus Daily Hydrating Moisturizer SPF 30Prevention Plus Daily Hydrating Moisturizer SPF 30

OTC - QUESTIONS SECTION

Call 800-796-7546

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
62742-4183-12022-01-28C16284748780-1d6a99b39-9f7c-a426-e053-dadaa90af4c2DRUG FACTS
62742-4183-32022-01-28C16284748780-1d6a99b39-9f7c-a426-e053-dadaa90af4c2DRUG FACTS
62742-4183-42022-01-28C16284748780-1d6a99b39-9f7c-a426-e053-dadaa90af4c2DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4183-1Prevention Plus Daily Hydrating Moisturizer SPF 30170 g in 1 TUBECREAM1701
62742-4183-2Prevention Plus Daily Hydrating Moisturizer SPF 3091 g in 1 TUBECREAM911
62742-4183-3Prevention Plus Daily Hydrating Moisturizer SPF 301 in 1 CARTONCREAM11
62742-4183-4Prevention Plus Daily Hydrating Moisturizer SPF 307 g in 1 TUBECREAM71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4183PREVENTION PLUS DAILY HYDRATING MOISTURIZER SPF 30 (ZINC OXIDE) CREAM [ALLURE LABS INC]1Legacy NDC, 4 package rows20191221_36db53e1-1e42-48ae-a3c8-aff59e4141a2.zip

Products#

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

DailyMed product names page 1 of 2 · 60 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-418362742-4183-1, 62742-4183-2, 62742-4183-3, 62742-4183-4

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 59 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
SHEANUT84H6HBP32LIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ISOSTEARIC ACIDX33R8U0062IACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CYCLOMETHICONE 6XHK3U310BAIACT
SUNFLOWER OIL3W1JG795YIIACT
POLYSILICONE-15F8DRP5BB29IACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
STEARETH-20 METHACRYLATEA268NZ57NBIACT
CITRUS AURANTIUM FRUIT OIL59JDQ5VT0TIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
LIMONENE, (+)-GFD7C86Q1WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALLANTOIN344S277G0ZIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAMINARIA DIGITATA15E7C67EE8IACT
ARTEMISIA VULGARIS WHOLEJDR81QW9ZQIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
MANDARIN OILNJO720F72RIACT
XANTHAN GUMTTV12P4NEEIACT
LEVOMENOL24WE03BX2TIACT
POLYSORBATE 806OZP39ZG8HIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
GREEN TEA LEAFW2ZU1RY8B0IACT

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
22ef5151-40ab-40d0-9f80-2f79c9166b1536db53e1-1e42-48ae-a3c8-aff59e4141a22019-12-11WarningsExact identifier
spl id: 22ef5151-40ab-40d0-9f80-2f79c9166b15
spl set id: 36db53e1-1e42-48ae-a3c8-aff59e4141a2

Reported adverse events (FAERS/openFDA)#

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