BLACK GIRL SUNSCREEN SUNSCREEN SPF 30 BROAD SPECTRUM- avobenzone, homosalate, octisalate, and octocrylene lotion

Black Girl Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Purpose

Sunscreen

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

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
• 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

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

• protect this product from excessive heat and direct sun

Black Girl Sunscreen Oxybenzone and Paraben Free Broad spectrum SPF 30 Moisturizing Sunscreen lotion Ultra Sheer Fragrance Free

INGREDIENTS AND APPEARANCE

BLACK GIRL SUNSCREEN  SUNSCREEN SPF 30 BROAD SPECTRUM
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.46 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	98.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.01 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
AVOCADO OIL (UNII: 6VNO72PFC1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCOA BUTTER (UNII: 512OYT1CRR)
CARROT SEED OIL (UNII: 595AO13F11)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
SUNFLOWER SEED (UNII: R9N3379M4Z)
HYPROMELLOSES (UNII: 3NXW29V3WO)
JOJOBA OIL (UNII: 724GKU717M)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	yellow (Colorless to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0250-3	88 mL in 1 TUBE; Type 0: Not a Combination Product	08/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/18/2017

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(58443-0250) , analysis(58443-0250) , pack(58443-0250) , label(58443-0250)