BU SPF 30 BROAD SPECTRUM ALCOHOL-FREE PERFORMANCE SUNSCREEN - NATURAL CITRUS SCENT- octinoxate, octocrylene, octisalate, and avobenzone spray

bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus Scent by

Drug Labeling and Warnings

bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus Scent by is a Otc medication manufactured, distributed, or labeled by Bu Brands, LLC, Westwood Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 7.50%
Octocrylene 7.50%
Octisalate 5.00%
Avobenzone 2.50%.

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.

Questions or Comments?

1.877.555.5555

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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.

Do not use near flame or while smoking

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
• Do not spray directly onto the face. Spray into hands, and apply to the face.
• children under 6 months: Ask a doctor
• 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-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Cyclopentasiloxane, Octyl Palmitate, Butyloctyl Salicylate, Diphenylsiloxy Phenyl Trimethicone, VP/Hexadecene Copolymer, Tocopherols, Bisabolol, Artemisia Pallens Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil.

Other Information

• protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

SPF30
broad
spectrum

spray-on
alcohol-free
performance
sunscreen

Oil-Free
Preservative-Free
Natural Citrus Scent

bü

Water Resistant
(80 Minutes)
1oz (30mL)

INGREDIENTS AND APPEARANCE

BU SPF 30 BROAD SPECTRUM ALCOHOL-FREE PERFORMANCE SUNSCREEN - NATURAL CITRUS SCENT 
octinoxate, octocrylene, octisalate, and avobenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70325-3003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
DAVANA OIL (UNII: CL439Y041G)
ORANGE OIL (UNII: AKN3KSD11B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70325-3003-3	98 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/01/2016
2	NDC: 70325-3003-1	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2016

Labeler - Bu Brands, LLC (080075929)

Establishment
Name	Address	ID/FEI	Business Operations
Westwood Laboratories,Inc.		069926483	MANUFACTURE(70325-3003)