FDA.reportPublic FDA data

Black Girl Sunscreen

Manufacturer
Prime Enterprises Inc. | Prime Enterprises Inc
Effective date
2023-07-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:28:34

Label at a glance#

ProductBlack Girl Sunscreen SPF 50 broad Spectrum
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
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 15%

Octisalate 5%

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 use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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
  • 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, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved 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, Butyrospermum Parkii (Shea) Butter, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Daucus Carota Sativa (Carrot) Seed Oil, Disodium EDTA, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Lecithin, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Sorbitan Oleate, Tocopheryl Acetate, Water

Other Information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Black Girl Sunscreen Kids Moisturizing Sunscreen Lotion for Face and Body 50 Broad Spectrum SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-062558443-0625-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
AVOCADO OIL6VNO72PFC1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARROT SEED OIL595AO13F11IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUNFLOWER SEEDR9N3379M4ZIACT
HYPROMELLOSES3NXW29V3WOIACT
JOJOBA OIL724GKU717MIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER 9804Q93RCW27EIACT
SODIUM HYDROXIDE55X04QC32IIACT
SHEA BUTTERK49155WL9YIACT
CHAMOMILEFGL3685T2XIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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
00c45ba8-b933-f7b0-e063-6394a90affd000c45ba4-e932-546a-e063-6294a90a0cfa2023-07-18WarningsExact identifier
spl id: 00c45ba8-b933-f7b0-e063-6394a90affd0
spl set id: 00c45ba4-e932-546a-e063-6294a90a0cfa

Reported adverse events (FAERS/openFDA)#

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