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.

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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)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2016

Labeler - Bu Brands, LLC (080075929)

Name	Address	ID/FEI	Business Operations
Establishment
Westwood Laboratories, Inc		832280635	MANUFACTURE(70325-3003)

bü SPF 30 Broad Spectrum Spray on Alcohol-Free Performance Sunscreen - Natural Citrus Scent