FDA.reportPublic FDA data

Black Girl Sunscreen Broad Spectrum SPF 30 Ultra Sheer Lotion

Manufacturer
Prime Enterprises Inc. | Prime Enterprises Inc
Effective date
2023-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:27:38

Label at a glance#

ProductBlack Girl Sunscreen Sunscreen SPF 30 broad Spectrum
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreses 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 inmediately 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 2.75%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctorif 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
  • after 80 minutes of swimming or sweating
  • inmediately 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, specially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats & sunglasses.
  • children under 6 months: Ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, Carbomer, Daucus Carota Sativa (Carrot) Seed Oil, Disodium EDTA, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Lecithin, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

Other Information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Black Girl Sunscreen SPF 30 Sunscreen Lotion for Face and Body

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-063658443-0636-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
AVOCADO OIL6VNO72PFC1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
COCOA BUTTER512OYT1CRRIACT
CARROT SEED OIL595AO13F11IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
SUNFLOWER SEEDR9N3379M4ZIACT
HYPROMELLOSES3NXW29V3WOIACT
JOJOBA OIL724GKU717MIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
SODIUM HYDROXIDE55X04QC32IIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
021ba779-7489-724a-e063-6394a90abe3e021ba76f-b991-bc75-e063-6394a90a08cb2023-08-04WarningsExact identifier
spl id: 021ba779-7489-724a-e063-6394a90abe3e
spl set id: 021ba76f-b991-bc75-e063-6394a90a08cb

Reported adverse events (FAERS/openFDA)#

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