Black Girl Make it Pop SPF 50 Sun Gloss for Lips

Black Girl Sunscreen by

Drug Labeling and Warnings

Black Girl Sunscreen by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BLACK GIRL SUNSCREEN SPF 50- octocrylene, octisalate, homosalate, avobenzone gel 
Prime Enterprises

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Black Girl Make it Pop SPF 50 Sun Gloss for Lips

Active ingredients

Octocrylene 9%

Octisalate 5%

Homosalate 4.5%

Avobenzone 3%

Purpose

Sunscreen

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

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

if rash occurs

Keep out of reach of children

If product is swalloed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply 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 am to 2 pm wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: ask a doctor

Inactive ingredients

Benzyl Alcohol, Butylene/Ethylene/Styrene Copolymer, C12-15 Alkyl Benzoate, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Olivate, Flavor, Glyceryl Caprylate, Glyceryl Undecylenate, Isohexadecane, Persea Gratissima (Avocado) Oil, Polyamide-3, Polybutene, Silica Cetyl Silylate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hyaluronate, Stevia Rebaudiana Leaf Extract, Tocopheryl Acetate, Tripeptide-1, Xanthan Gum

Other Information

protect this product from excessive heat and direct sun

Black Girl Make it Pop SPF 50 Sun Gloss for Lips

BLACK GIRL SUNSCREEN  SPF 50
octocrylene, octisalate, homosalate, avobenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0632
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	44.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	26.7 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	40.05 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYAMIDE-3 (20000 MW) (UNII: PLF06VZ9SQ)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
STEVIA LEAF (UNII: 6TC6NN0876)
1-BUTENE (UNII: LY001N554L)
ETHYLENE (UNII: 91GW059KN7)
STYRENE (UNII: 44LJ2U959V)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
ISOHEXADECANE (UNII: 918X1OUF1E)
AVOCADO OIL (UNII: 6VNO72PFC1)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
JOJOBA OIL (UNII: 724GKU717M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PROPYLENE (UNII: AUG1H506LY)
PREZATIDE (UNII: 39TG2H631E)

Product Characteristics
Color	yellow (Hint of Yellow to Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0632-2	4 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	08/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	08/04/2023

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	analysis(58443-0632) , label(58443-0632) , manufacture(58443-0632) , pack(58443-0632)

Revised: 8/2023

Document Id: 021a3ae9-d824-faa9-e063-6394a90acbb0

34390-5

Set id: 021a3ae9-d823-faa9-e063-6394a90acbb0

Version: 1

Effective Time: 20230804