WHITE GIRL SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion

White Girl Sunscreen by

Drug Labeling and Warnings

White Girl Sunscreen by is a Otc medication manufactured, distributed, or labeled by White Girl, LLC, Bath Concept Cosmetics (Dongguan) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7%

Homosalate 3%

Octocrylene 6%

Avobenzone 2.5%

Drug Facts

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 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 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in the sun increasess your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum spf of 30 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m-2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Other Information

protect this product from excessive heat and direct sun

White Girl Sunscreen 30 SPF

White Girl Sunscreen 30 SPF

www.whitegirlsunscreen.com

INGREDIENTS AND APPEARANCE

WHITE GIRL SUNSCREEN 
avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70641-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STEARETH-21 (UNII: 53J3F32P58)	1.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70641-111-01	100 g in 1 POUCH; Type 0: Not a Combination Product	06/06/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/06/2016

Labeler - White Girl, LLC (080196333)

Registrant - Bath Concept Cosmetics (Dongguan) Co., Ltd. (529623933)

Establishment
Name	Address	ID/FEI	Business Operations
Bath Concept Cosmetics (Dongguan) Co., Ltd.		529623933	manufacture(70641-111)