FDA.reportPublic FDA data

Gentle Hydrating Sunscreen Broad Spectrum SPF 30

Manufacturer
Allure Labs Inc
Effective date
2020-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:30

Label at a glance#

ProductGentle Hydrating Sunscreen Broad Spectrum SPF 30
Active ingredientZINC OXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Zinc Oxide 18.9%

OTC - PURPOSE SECTION

Purpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses:

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Direction), this product 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 product: Keep out of eyes. 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 product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply generously 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a doctor. 
  • Reapply 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 10am - 2pm.
  • Wear long sleeved shirts, pants, hats and sunglasses.

OTHER SAFETY INFORMATION

Other Information: Protect the product from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Malus (Apple) Fruit Extract, Coco-Glucoside, Cetearyl Glucoside, Caprylyl/Capryl Glucoside, Dipotassium Glycyrrhizate, Camellia Sinensis Leaf Extract, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Sodium Phytate, Lecithin, Tocopherol, Xanthan Gum, Sclerotium Gum, Phenoxyethanol, Ethylhexylglycerin,  Sodium Benzoate, Potassium Sorbate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured by Allure Labs

For Eczema Honey CO IN

Partnership:

Hayward, CA, 94545

Gentle Hydrating Sunscreen Broad Spectrum SPF 30Gentle Hydrating Sunscreen Broad Spectrum SPF 30

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62742-4189-12022-01-28C16284748780-1d6a99b39-af1b-a426-e053-dadaa90af4c2DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4189-1Gentle Hydrating Sunscreen Broad Spectrum SPF 3057 g in 1 TUBECREAM571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4189GENTLE HYDRATING SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) CREAM [ALLURE LABS INC]1Legacy NDC, 1 package rows20200902_291bbf47-e702-4776-8ed8-3f16232f6506.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-418962742-4189-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT ALKANES1E5KJY107TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCO GLUCOSIDEICS790225BIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
APPLEB423VGH5S9IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SHEANUT84H6HBP32LIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
HEXASODIUM PHYTATEZBX50UG81VIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
XANTHAN GUMTTV12P4NEEIACT
TOCOPHEROLR0ZB2556P8IACT
BETASIZOFIRAN2X51AD1X3TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
6add06a9-bb42-4b3b-a1ac-455262b0c966291bbf47-e702-4776-8ed8-3f16232f65062020-08-24WarningsExact identifier
spl id: 6add06a9-bb42-4b3b-a1ac-455262b0c966
spl set id: 291bbf47-e702-4776-8ed8-3f16232f6506

Reported adverse events (FAERS/openFDA)#

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