Mineral SPF 15 Broad Spectrum Lip Balm

Manufacturer: Raining Rose, Inc
Effective date: 2023-10-18
Label type: HUMAN OTC DRUG LABEL
Version: 30
Source: full-release
Hydrated at: 2026-05-31 23:56:55

Label at a glance#

ProductMineral SPF 15 Broad Spectrum Lip Balm

Active ingredientZINC OXIDE

Label structure12 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months of age: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

Stop Use and ask a doctor if

OTC - STOP USE SECTION

Rash Occurs

When Using this Product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse well with water to remove.

Keep out of reach of children

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.

Directions

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours
Children under 6 months of age: Ask a doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Sunflower Oil*, Beeswax, Olive Oil*, Tocopherol, Aloe Extract, Canola Oil, Soybean Oil. * Organic

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C10873 SPF 15 UNFLAVORED MINERAL LIP BALM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65692-0515-1	Mineral SPF 15 Broad Spectrum Lip Balm	4.25 g in 1 TUBE	STICK	4.25		30

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65692-0515	MINERAL SPF 15 BROAD SPECTRUM LIP BALM STICK [RAINING ROSE, INC]	30	Current NDC, Legacy NDC, 1 package rows	20231019_44d2759a-d95d-7525-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Mineral SPF 15 Broad Spectrum Lip Balm
CANOLA OIL
ZINC OXIDE
SUNFLOWER OIL
TOCOPHEROL
WHITE WAX
OLIVE OIL
ALOE VERA LEAF
SOYBEAN OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65692-0515	65692-0515-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CANOLA OIL	331KBJ17RK	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB
SUNFLOWER OIL	3W1JG795YI	IACT
TOCOPHEROL	R0ZB2556P8	IACT
WHITE WAX	7G1J5DA97F	IACT
OLIVE OIL	6UYK2W1W1E	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
SOYBEAN OIL	241ATL177A	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral SPF 15 Broad Spectrum Lip Balm	MINERAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	44d2759a-d95d-7525-e054-00144ff88e88	2023-10-18	Warnings	Exact identifier ndc (package): 65692-0515-1 ndc (product): 65692-0515 ndc11 (package): 65692051501 spl id: 080489ba-9d55-80cd-e063-6394a90ac0a0 spl set id: 44d2759a-d95d-7525-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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