FDA.reportPublic FDA data

Black Girl Sunscreen Broad Spectrum SPF 45 Ultra Sheer Sunscreen Gel

Manufacturer
Prime Enterprises, Inc.
Effective date
2021-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:13

Label at a glance#

ProductBlack Girl Sunscreen SPF 45
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE
Label structure8 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 of 15 or higher and other sun protection measures including: limit time in the sun, ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

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:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

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 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-sleeved shirts, pants, hats and sunglasses

children under 6 months: Ask a doctor.

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf Extract, Butyrospermum Parkii (Shea) Butter, Cetyl Ethylhexanoate, Cocoa Nucifera (Coconut) Oil, Diisopropyl Adipate, Diisopropyl Sebacate, Neopentyl Glycol Diethylhexanoate, Silica, Silica Silylate, Squalane, Tocopheryl Acetate, VP/Hexadecene Copolymer

Other information

SPL UNCLASSIFIED SECTION

Protect this product form excessive heat and direct sun

PRINCIPAL DISPLAY LABEL - 1.7oz Black Girl Sunscreen Broad Spectrum SPF 45 Ultra Sheer Sunscreen Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0415-32023-01-30C16284748780-1f386c649-de46-0266-e053-dadaa90a7c1aBlack Girl Sunscreen Broad Spectrum SPF 45 Ultra Sheer Sunscreen Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0415-3Black Girl SunscreenSPF 4550 mL in 1 TUBEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0415BLACK GIRL SUNSCREEN SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [PRIME ENTERPRISES, INC.]1Legacy NDC, 1 package rows20210901_cac97035-cf69-4019-e053-2a95a90a4920.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-041558443-0415-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ETHYLHEXANOATE134647WMX4IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
COCONUT OILQ9L0O73W7LIACT
SHEA BUTTERK49155WL9YIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
OCTOCRYLENE5A68WGF6WMACTIB
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
ALOE VERA LEAFZY81Z83H0XIACT
HOMOSALATEV06SV4M95SACTIB
SQUALANEGW89575KF9IACT

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
cac97035-cf6a-4019-e053-2a95a90a4920cac97035-cf69-4019-e053-2a95a90a49202021-08-30WarningsExact identifier
spl id: cac97035-cf6a-4019-e053-2a95a90a4920
spl set id: cac97035-cf69-4019-e053-2a95a90a4920

Reported adverse events (FAERS/openFDA)#

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