FDA.reportPublic FDA data

Desert Spirit Lip Balm SPF 15

Manufacturer
R & R Lotion, Inc
Effective date
2020-10-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:11

Label at a glance#

ProductIndustrial Lip Balm SPF 15
Active ingredientOctinoxate, Oxybenzone
Label structure13 sections

Indications and uses

Helps prevent sunburn

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: Ask a doctor

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzophenone-3 (Oxybenzone) 3%
Ethylhexyl Methoxycinnamate (Octinoxate) 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

  • Skin Cancer/Skin Aging Alert: 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 - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

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

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

DOSAGE & ADMINISTRATION SECTION

  • 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: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Extract, Copernicia Cerifera (Carnauba) Wax, Flavor, Mineral Oil, Paraffin, Petrolatum, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E), Zea Mays (Corn) Oil (and) BHA (and) Propyl Gallate (and) Citric Acid.

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-262-268-2720

SPL UNCLASSIFIED SECTION

Manufactured by: Alliance Packaging Group, Inc. Saukville, WI 53080

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Industrial

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INDUSTRIAL
LIPBALM
SPF 15

LIME BURST
LIP BALM

PN# ISLB

Net Wt. : 0.15 oz / 4.2 g

Peel label
for drug
facts info.

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Industrial
PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Industrial

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Clean Balm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Peel label
for drug
facts info.

R&R
LOTION®
I.C. CLEAN BALM SPF 15 ™

LIME BURST
LIP BALM

PN# ISLB

Net Wt. : 0.15 oz / 4.2 g

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Clean Balm
PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Clean Balm

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Desert Spirit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DESERT SPIRIT

SPF 15
Lip Protection

Net Wt. : 0.15 oz / 4.2 g

Peel label
for drug
facts info.

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Desert Spirit
PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Desert Spirit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59555-111-202022-01-28C16284748780-1d6a99b39-7df5-a426-e053-dadaa90af4c2Lip Balm SPF 15
59555-112-202022-01-28C16284748780-1d6a99b39-7df5-a426-e053-dadaa90af4c2Lip Balm SPF 15
59555-113-202022-01-28C16284748780-1d6a99b39-7df5-a426-e053-dadaa90af4c2Lip Balm SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59555-111-20Industrial Lip Balm SPF 154.2 g in 1 APPLICATORLIPSTICK4.21
59555-112-20Cleanroom Lip Balm SPF 154.2 g in 1 APPLICATORLIPSTICK4.21
59555-113-20Desert Spirit Lip Balm SPF 154.2 g in 1 APPLICATORLIPSTICK4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59555-111INDUSTRIAL LIP BALM SPF 15 (OCTINOXATE AND OXYBENZONE) LIPSTICK CLEANROOM LIP BALM SPF 15 (OCTINOXATE AND OXYBENZONE) LIPSTICK DESERT SPIRIT LIP BALM SPF 15 (OCTINOXATE AND OXYBENZONE) LIPSTICK [R & R LOTION, INC]1Legacy NDC, 1 package rows20201022_28942754-8f2c-442b-abc9-113c2f0982b6.zip
59555-112INDUSTRIAL LIP BALM SPF 15 (OCTINOXATE AND OXYBENZONE) LIPSTICK CLEANROOM LIP BALM SPF 15 (OCTINOXATE AND OXYBENZONE) LIPSTICK DESERT SPIRIT LIP BALM SPF 15 (OCTINOXATE AND OXYBENZONE) LIPSTICK [R & R LOTION, INC]1Legacy NDC, 1 package rows20201022_28942754-8f2c-442b-abc9-113c2f0982b6.zip
59555-113INDUSTRIAL LIP BALM SPF 15 (OCTINOXATE AND OXYBENZONE) LIPSTICK CLEANROOM LIP BALM SPF 15 (OCTINOXATE AND OXYBENZONE) LIPSTICK DESERT SPIRIT LIP BALM SPF 15 (OCTINOXATE AND OXYBENZONE) LIPSTICK [R & R LOTION, INC]1Legacy NDC, 1 package rows20201022_28942754-8f2c-442b-abc9-113c2f0982b6.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
59555-11159555-111-20
59555-11259555-112-20
59555-11359555-113-20

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Oxybenzone95OOS7VE0YACTIB
WATER059QF0KO0RIACT
Carnauba WaxR12CBM0EIZIACT
Mineral OilT5L8T28FGPIACT
ParaffinI9O0E3H2ZEIACT
Petrolatum4T6H12BN9UIACT
Vitamin A Palmitate1D1K0N0VVCIACT
Jojoba Oil724GKU717MIACT
Cocoa Butter512OYT1CRRIACT
Corn Oil8470G57WFMIACT
Propyl Gallate8D4SNN7V92IACT
Citric Acid Monohydrate2968PHW8QPIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
Octinoxate4Y5P7MUD51ACTIB
Oxybenzone95OOS7VE0YACTIB
WATER059QF0KO0RIACT
Carnauba WaxR12CBM0EIZIACT
Mineral OilT5L8T28FGPIACT
ParaffinI9O0E3H2ZEIACT
Petrolatum4T6H12BN9UIACT
Vitamin A Palmitate1D1K0N0VVCIACT
Jojoba Oil724GKU717MIACT
Cocoa Butter512OYT1CRRIACT
Corn Oil8470G57WFMIACT
Propyl Gallate8D4SNN7V92IACT
Citric Acid Monohydrate2968PHW8QPIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
Octinoxate4Y5P7MUD51ACTIB
Oxybenzone95OOS7VE0YACTIB
WATER059QF0KO0RIACT
Carnauba WaxR12CBM0EIZIACT
Mineral OilT5L8T28FGPIACT
ParaffinI9O0E3H2ZEIACT
Petrolatum4T6H12BN9UIACT
Vitamin A Palmitate1D1K0N0VVCIACT
Jojoba Oil724GKU717MIACT
Cocoa Butter512OYT1CRRIACT
Corn Oil8470G57WFMIACT
Propyl Gallate8D4SNN7V92IACT

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
bda160ee-9bb4-4fbd-86d6-355cc7f39b2828942754-8f2c-442b-abc9-113c2f0982b62020-10-20WarningsExact identifier
spl id: bda160ee-9bb4-4fbd-86d6-355cc7f39b28
spl set id: 28942754-8f2c-442b-abc9-113c2f0982b6

Reported adverse events (FAERS/openFDA)#

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