FDA.reportPublic FDA data

SPF Rx - SPF 30 Mango Lip Balm

Manufacturer
Cal Pharma LLC | Health Specialty
Effective date
2017-07-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:14:30

Label at a glance#

ProductSPF Rx - SPF 30 Mango Lip Balm
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure7 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeve shirts, pants, hats...

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS

WARNINGS AND PRECAUTIONS 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.

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 liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. - 2 p.m.

• wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months. Ask a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Olea Europaea (Olive) Fruit Oil, Flavor, Cannabis Sativa (Hemp) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Aloe Barbadensis Leaf Extract.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Protect this product from direct sun and excessive heat.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label_SPF Rx - SPF 30 Mango Lip Balm_PrimaryLabel_SPF Rx - SPF 30 Mango Lip Balm_Primary

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55628-9565-02024-04-01C16284748780-1d6a99b39-b6df-a426-e053-dadaa90af4c2f0e2a7a7-208c-4257-81b7-5581e38cea72
55628-9565-02022-01-28C16284748780-1d6a99b39-b6df-a426-e053-dadaa90af4c2f0e2a7a7-208c-4257-81b7-5581e38cea72

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55628-956555628-9565-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
SUNFLOWER OIL3W1JG795YIIACT
WHITE WAX7G1J5DA97FIACT
OLIVE OIL6UYK2W1W1EIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
ROSEMARYIJ67X351P9IACT
TOCOPHEROLR0ZB2556P8IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
150e57ad-3eca-5cc9-e063-6394a90a25fef0e2a7a7-208c-4257-81b7-5581e38cea722024-04-01WarningsExact identifier
spl set id: f0e2a7a7-208c-4257-81b7-5581e38cea72

Reported adverse events (FAERS/openFDA)#

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