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 useon damaged or broken skin

When using this product

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

Stop use and ask a doctor

Stop use and ask a doctorif 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.

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

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

Principal Display Label

BLACK GIRL SUNSCREEN SPF 45
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0629
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	95 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.5 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.5 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	95 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0629-3	50 mL in 1 TUBE; Type 0: Not a Combination Product	08/04/2023

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

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(58443-0629) , label(58443-0629) , analysis(58443-0629) , pack(58443-0629)

Revised: 8/2023

Document Id: 021990b8-d54c-44c6-e063-6294a90aa8f4

Set id: 021999ee-8dce-52cb-e063-6294a90a5594

Version: 1

Effective Time: 20230804

Prime Enterprises, Inc.