FDA.reportPublic FDA data

Broad Spectrum SPF 15 Coconut Lip Balm

Manufacturer
Raining Rose, Inc.
Effective date
2023-11-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:46

Label at a glance#

ProductBroad Spectrum SPF 15 Coconut Lip Balm
Active ingredientZINC OXIDE
Label structure13 sections

Indications and uses

Helps prevent sunburn

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: 

Zinc Oxide 3.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

WARNINGS SECTION

Warnings

For External Use Only 

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - STOP USE SECTION


Stop use and as a doctor if rash occurs

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions Apply liberally 15 minutes before sun exposure •
• Use a water resistant sunscreen if swimming or sweatinb •Reapply
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 protection measures
including: limit time in the sun, especially from 10a.m. - 2p.m. • wear
long-sleeved shirts, pants, hats and sunglasses.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  Organic Calendula, Organic Comfrey,

Organic Lavender, Organic Plantain and Organic Yarrow Infused in

Organic Extra Virgin Olive Oil with Organic Beeswax, Organic

Coconut Flavor and Non-GMO Vitamin E.

SPL UNCLASSIFIED SECTION

Other Information

Protect this product from excessive heart and direct sun.

Product Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UVA/UVB BROAD SPECTRUM SPF 15

Coconut Lip Balm

NET WT. 4.25g

DIST. BY ALLGOODPRODUCTS.COM, MORRO BAY, CA 93443            L000000

03070307

res

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-0307-1Broad Spectrum SPF 15 Coconut Lip Balm4.25 g in 1 TUBESTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0307BROAD SPECTRUM SPF 15 COCONUT LIP BALM (ZINC OXIDE) STICK [RAINING ROSE, INC.]2Current NDC, Legacy NDC, 1 package rows20231104_2a03abc4-824b-438d-acc5-469853057679.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65692-030765692-0307-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
COMFREY LEAFDG4F8T839XIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
PLANTAGO MAJOR LEAF7DC28K241XIACT
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAIACT
OLIVE OIL6UYK2W1W1EIACT
YELLOW WAX2ZA36H0S2VIACT
TOCOPHEROLR0ZB2556P8IACT

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
Broad Spectrum SPF 15 Coconut Lip BalmZINC OXIDERaining Rose, Inc.2a03abc4-824b-438d-acc5-4698530576792023-11-03WarningsExact identifier
ndc (package): 65692-0307-1
ndc (product): 65692-0307
ndc11 (package): 65692030701
spl id: 0decf6f7-de38-4584-8bfe-83596fb81e25
spl set id: 2a03abc4-824b-438d-acc5-469853057679

Reported adverse events (FAERS/openFDA)#

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