FDA.reportPublic FDA data

SPF 8 Lip Moisturizers

Manufacturer
Juice Beauty
Effective date
2023-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:00

Label at a glance#

ProductSPF 8 Lip Moisturizers
Active ingredientZinc Oxide
Label structure10 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply generously before sun exposure and as needed. Children under 6 months of age, ask a doctor. Generously glide over lips and use often.

Storage and handling

Minimal sun protection product. Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

Skin Cancer/ Skin Aging Alert

SPL UNCLASSIFIED SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply generously before sun exposure and as needed. Children under 6 months of age, ask a doctor. Generously glide over lips and use often.

Other Information

STORAGE AND HANDLING SECTION

Minimal sun protection product. Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Organic plant oils of helianthus annuus (organic sunflower seed oil)1, ricinus communis (organic castor seed oil)1, euphorbia cerifera (candelilla wax), theobroma cacao (organic cocoa seed butter)1, cocos nucifera (organic coconut oil)1, fragaria ananassa (organic strawberry flavor)1, aloe barbadensis (organic aloe oil)1, vaccinium corymbosum (organic blueberry flavor)1, tocopherol (Vitamin E). May contain titanium dioxide, mica, iron oxides.

1 certified organic ingredient

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

juice BEAUTY
THE ORGANIC SOLUTION™

SPF 8 Lip Moisturizers
.15 oz / 4.25 g ea

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55165-0201-12025-01-30C16284748780-12cef2736-74be-d83d-e063-dadaa90ab31fSPF 8 Lip Moisturizers

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55165-0201-1SPF 8 Lip Moisturizers1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55165-0201SPF 8 LIP MOISTURIZERS (ZINC OXIDE) KIT [JUICE BEAUTY]2Legacy NDC, 1 package rows20230111_7d2cd20c-4143-4262-a179-2a3ba5b3f6c0.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55165-020155165-0201-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Sunflower Oil3W1JG795YIIACT
Candelilla WaxWL0328HX19IACT
COCOA BUTTER512OYT1CRRIACT
Coconut OilQ9L0O73W7LIACT
Castor OilD5340Y2I9GIACT
FERRIC OXIDE RED1K09F3G675IACT
ALOE VERA LEAFZY81Z83H0XIACT
TOCOPHEROLR0ZB2556P8IACT
MicaV8A1AW0880IACT
Titanium Dioxide15FIX9V2JPIACT
Zinc OxideSOI2LOH54ZACTIB
Sunflower Oil3W1JG795YIIACT
Candelilla WaxWL0328HX19IACT
COCOA BUTTER512OYT1CRRIACT
Coconut OilQ9L0O73W7LIACT
Castor OilD5340Y2I9GIACT
ALOE VERA LEAFZY81Z83H0XIACT
TOCOPHEROLR0ZB2556P8IACT
Zinc OxideSOI2LOH54ZACTIB
Sunflower Oil3W1JG795YIIACT
Candelilla WaxWL0328HX19IACT
COCOA BUTTER512OYT1CRRIACT
Coconut OilQ9L0O73W7LIACT
Castor OilD5340Y2I9GIACT
FERRIC OXIDE RED1K09F3G675IACT
ALOE VERA LEAFZY81Z83H0XIACT
TOCOPHEROLR0ZB2556P8IACT
MicaV8A1AW0880IACT
Titanium Dioxide15FIX9V2JPIACT

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
5692792b-73e1-43e3-a57f-ef14f5f4e91c7d2cd20c-4143-4262-a179-2a3ba5b3f6c02023-01-05WarningsExact identifier
spl id: 5692792b-73e1-43e3-a57f-ef14f5f4e91c
spl set id: 7d2cd20c-4143-4262-a179-2a3ba5b3f6c0

Reported adverse events (FAERS/openFDA)#

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