Black Girl Sunscreen Make It Pop Sungloss for LIps Broad Spectrum SPF 50

Black Girl Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

BLACK GIRL SUNSCREEN SUNGLOSS FOR LIPS- lidocaine hydrochloride gel 
Prime Enterprises Inc.

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Black Girl Sunscreen Make It Pop Sungloss for LIps Broad Spectrum SPF 50

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 swallowed, 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 the 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 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 Sunscreen Make It Pop Sun Gloss for LIps Broad spectrum SPF 50

BLACK GIRL SUNSCREEN  SUNGLOSS FOR LIPS
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0606
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	40.05 mg  in 1 mL
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
ISOHEXADECANE (UNII: 918X1OUF1E)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
ETHYLHEXYL OLEATE (UNII: R34927QY59)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
JOJOBA OIL (UNII: 724GKU717M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
AVOCADO OIL (UNII: 6VNO72PFC1)
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: 58443-0606-2	4 mL in 1 TUBE; Type 0: Not a Combination Product	01/10/2023	08/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/10/2023	08/13/2024

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0606) , manufacture(58443-0606) , label(58443-0606) , analysis(58443-0606)

Revised: 8/2024

Document Id: 1f92e85c-19cf-06e7-e063-6294a90a89bd

34390-5

Set id: f1f05b78-915f-b4ab-e053-2995a90a93b5

Version: 3

Effective Time: 20240813