BLACK GIRL SUNSCREEN SPF 45- avobenzone, homosalate, octisalate, octocrylene gel 
Prime Enterprises, Inc.

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.

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Black Girl Sunscreen Broad Spectrum SPF 45 Ultra Sheer Sunscreen Gel

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

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

Do not use on damaged or broken skin

When using this product

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

Stop use and ask a doctor

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

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

immediately 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 and sunglasses

children under 6 months: Ask a doctor.

Aloe Vera Leaf Extract, Butyrospermum Parkii (Shea) Butter, Cetyl Ethylhexanoate, Cocoa Nucifera (Coconut) Oil, Diisopropyl Adipate, Diisopropyl Sebacate, Neopentyl Glycol Diethylhexanoate, Silica, Silica Silylate, Squalane, Tocopheryl Acetate, VP/Hexadecene Copolymer

Other information

Protect this product form excessive heat and direct sun

PRINCIPAL DISPLAY LABEL - 1.7oz Black Girl Sunscreen Broad Spectrum SPF 45 Ultra Sheer Sunscreen Gel

Principle Display Label

BLACK GIRL SUNSCREEN  SPF 45
avobenzone, homosalate, octisalate, octocrylene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0415
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE95 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE95 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SQUALANE (UNII: GW89575KF9)  
Product Characteristics
Coloryellow (Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0415-350 mL in 1 TUBE; Type 0: Not a Combination Product05/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/11/2021
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(58443-0415) , label(58443-0415) , analysis(58443-0415) , pack(58443-0415)

Revised: 8/2021
Document Id: cac97035-cf6a-4019-e053-2a95a90a4920
Set id: cac97035-cf69-4019-e053-2a95a90a4920
Version: 1
Effective Time: 20210830
 
Prime Enterprises, Inc.