FDA.reportPublic FDA data

Broad Spectrum SPF 30 Sunscreen

Manufacturer
Raining Rose
Effective date
2023-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:58

Label at a glance#

ProductBroad Spectrum SPF 30 Sunscreen
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply after 80 minutes of swimming or sweating Reapply immediately after towel drying 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...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Zinc Oxide (18.75%) Non-nanoparticle

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings:

WARNINGS SECTION

  • For external use only
  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of readh 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
  • Reapply after 80 minutes of swimming or sweating
  • Reapply immediately after towel drying
  • 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 sun protection measures including:

  • Limit time in the sun, especially from 10a.m.-2p.m.
  • wear long sleeved shirts, pants, hats and sunglasses.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sunflower Oil*, Beeswax*, Jojoba Oil*, Coconut Oil*, Tocopherol (Non-GMO). *Organic

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

c10738 c10737b-01c10738 c10737b-01Broad Spectrum SPF 30 Sunscreen

Natural Mineral Formula

Water Resistant

(80 minutes)

1.5 fl.oz./44 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65692-0566-1Broad Spectrum SPF 30 Sunscreen44 mL in 1 BOTTLE, PLASTICLOTION442

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65692-0566BROAD SPECTRUM SPF 30 SUNSCREEN LOTION [RAINING ROSE]2Current NDC, Legacy NDC, 1 package rows20231019_c23d49bd-8447-4920-e053-2a95a90a0a06.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65692-056665692-0566-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WHITE WAX7G1J5DA97FIACT
ZINC OXIDESOI2LOH54ZACTIB
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
COCONUT OILQ9L0O73W7LIACT
SUNFLOWER OIL3W1JG795YIIACT

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 30 SunscreenBROAD SPECTRUM SPF 30 SUNSCREENRaining Rosec23d49bd-8447-4920-e053-2a95a90a0a062023-10-18WarningsExact identifier
ndc (package): 65692-0566-1
ndc (product): 65692-0566
ndc11 (package): 65692056601
spl id: 08037ad4-2b3e-2824-e063-6294a90ac6da
spl set id: c23d49bd-8447-4920-e053-2a95a90a0a06

Reported adverse events (FAERS/openFDA)#

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