FDA.reportPublic FDA data

Lip Orange Vanilla

Manufacturer
Crossing Cultures LLC dba Goddess Garden
Effective date
2018-05-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:28

Label at a glance#

ProductLip Orange Vanilla SPF30
Active ingredientZINC OXIDE
Label structure13 sections

Indications and uses

* 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.

Dosage and administration

* Apply liberally 15 minutes before sun exposure. * Reapply: - After 80 minutes of swimming or sweating. - Immediately after towel drying. - At least every 2 hours. * Children under 6 months of age: Ask a doctor. * Sun Protection Measures: Spending time in the sun increases 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 highe...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 8.55%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

* 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.

Warnings

WARNINGS SECTION

* For external use only.

* Do not use on damaged or broken skin.

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

* Stop use and ask a doctor if rash occurs.

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

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water and remove.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

* Apply liberally 15 minutes before sun exposure.

* Reapply:

- After 80 minutes of swimming or sweating.

- Immediately after towel drying.

- At least every 2 hours.

* Children under 6 months of age: Ask a doctor.

* Sun Protection Measures: Spending time in the sun increases 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 sun, especially from 10a.m. to 2p.m.

- Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

OTHER SAFETY INFORMATION

* Protect this product from excessive heat and direct sun.

* Store at temperatures below 90'F.

* May Stain some fabrics or surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bisabolol, Butyrospermum Parkii (Shea Butter)*, Calophyllum Inophyllum (Tamanu) Oil*, Capric/Caprylic Triglyceride (Fractionated Coconut Oil), Citrus Aurantium Dulcis (Orange) Peel Oil*, Cocos Nucifera (Coconut) Oil*, Copernicia Cerifera (Carnauba) Wax*, Euphorbia Cerifera (Candelilla) Wax, Natural Flavor*, Olea Europaea (Olive) Oil*, Pongamia Glabra (Karanja) Seed Oil*, Schinziophyton Rautanenii (Mongongo) Kernel Oil*, Stearic Acid, Stevia Rebaudiana Leaf/Stem Extract, Theobroma Cacao (Cocoa) Seed Butter*, Theobroma Grandiflorum (Cupuacu) Butter*, Tocopherol

*Organic

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orange VanillaOrange Vanilla

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58479-639-042021-01-29C16284748780-1ba0f9c33-0e47-a910-e053-dadaa90a0b85Goddess Garden Orange Vanilla SPF30 Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58479-639-04Lip Orange VanillaSPF304 g in 1 TUBESTICK41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58479-639LIP ORANGE VANILLA SPF30 (ZINC OXIDE) STICK [CROSSING CULTURES LLC DBA GODDESS GARDEN]1Legacy NDC, 1 package rows20180509_6bb8a5db-ea5b-8445-e053-2a91aa0a5aa5.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58479-63958479-639-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
LEVOMENOL24WE03BX2TIACT
COCONUT OILQ9L0O73W7LIACT
CARNAUBA WAXR12CBM0EIZIACT
OLIVE OIL6UYK2W1W1EIACT
SCHINZIOPHYTON RAUTANENII SEED OIL6GSJ7A6T1EIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
THEOBROMA GRANDIFLORUM SEED BUTTERI711F13FXMIACT
STEARIC ACID4ELV7Z65APIACT
ORANGE OILAKN3KSD11BIACT
CANDELILLA WAXWL0328HX19IACT
COCOA BUTTER512OYT1CRRIACT
TOCOPHEROLR0ZB2556P8IACT
TAMANU OILJT3LVK84A1IACT
KARUM SEED OIL62160PU6FJIACT

Source Document#

Source XML · Source PDF

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
6bb8a5db-ea5c-8445-e053-2a91aa0a5aa56bb8a5db-ea5b-8445-e053-2a91aa0a5aa52018-05-08WarningsExact identifier
spl id: 6bb8a5db-ea5c-8445-e053-2a91aa0a5aa5
spl set id: 6bb8a5db-ea5b-8445-e053-2a91aa0a5aa5

Reported adverse events (FAERS/openFDA)#

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