Active Ingredients

Avobenzone 3%, Homosalate 7.5%, Octisalate 5%, Octocrylene 5%

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 10am - 2pm

Wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

Other Information

Protect this product from excessive heat and direct sun

Questions or comments?

Call (631) 800-7SPF (800-7773) or hello@basksuncare.com

Bask Suncare Broad Spectrum Sunscreen SPF 30 Lotion - 0.25 Fl. Oz

Principle Display Label

BASK SUNCARE BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0418
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.16 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	72.9 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	48.6 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48.6 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HYPROMELLOSES (UNII: 3NXW29V3WO)
COCOA BUTTER (UNII: 512OYT1CRR)

Product Characteristics
Color	white (White)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0418-2	7.39 mL in 1 TUBE; Type 0: Not a Combination Product	01/22/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/22/2019

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(58443-0418) , label(58443-0418) , analysis(58443-0418) , pack(58443-0418)