FDA.reportPublic FDA data

Black Girl Mineral Combo Sunscreen Lotion for Face & Body Broad Spectrum SPF 50

Manufacturer
Prime Enterprises Inc. | Prime Enterprises Inc
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
dailymed-archive
Hydrated at
2026-08-01 20:22:26

Label at a glance#

ProductBlack Girl Sunscreen SPF 50 broad Spectrum
Active ingredientOCTOCRYLENE, ZINC OXIDE, 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, 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

Acrylic Acid/VP Crosspolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Daucus Carota Sativa (Carrot) Seed Oil, Ethyl Ferulate, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Oil, Olus Oil, Persea Gratissima (Avocado) Oil, Pongamia Pinnata Seed Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Tetrasodium Glutamate Diacetate , Tocopheryl Acetate, Triethoxycaprylylsilane, VP/Acrylates/Lauryl Methacrylate Copolymer, Water

Other Information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Black Girl Sunscreen Mineral Combo Sunscreen Lotion for Face & Body 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 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-050958443-0509-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL CAPRYLATETM2TZD4G4AIACT
CORN OIL8470G57WFMIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
OCTOCRYLENE5A68WGF6WMACTIB
LAVENDER OILZBP1YXW0H8IACT
ETHYL FERULATE5B8915UELWIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
MILLETTIA PINNATA SEEDC2BRV53B1VIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
AVOCADO OIL6VNO72PFC1IACT
CARROT SEED OIL595AO13F11IACT
WATER059QF0KO0RIACT
SUNFLOWER SEEDR9N3379M4ZIACT
JOJOBA OIL724GKU717MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM HYDROXIDE55X04QC32IIACT
SHEA BUTTERK49155WL9YIACT
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER7K68DGG29PIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ZINC OXIDESOI2LOH54ZACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT

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
d58e9a2a-afc4-3f27-e053-2a95a90a34abd58ea783-8ac2-71f0-e053-2995a90a19152022-01-14WarningsExact identifier
spl id: d58e9a2a-afc4-3f27-e053-2a95a90a34ab
spl set id: d58ea783-8ac2-71f0-e053-2995a90a1915

Reported adverse events (FAERS/openFDA)#

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