BU SPF 50 KIDS BROAD SPECTRUM ALCOHOL-FREE PERFORMANCE SUNSCREEN - FRAGRANCE FREE- octinoxate, octocrylene, octisalate, avobenzone, and homosalate spray

bu SPF 50 KIDS Broad Spectrum Alcohol-Free Performance Sunscreen - Fragrance Free by

Drug Labeling and Warnings

bu SPF 50 KIDS Broad Spectrum Alcohol-Free Performance Sunscreen - Fragrance Free 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

Octocrylene 10.00%
Octinoxate 7.50%
Homosalate 7.50%
Octisalate 5.00%
Avobenzone 3.00%

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

• 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, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Diphenylsiloxy Phenyl Trimethicone, VP/Hexadecene Copolymer (and) Octyldodecanol, Polybutene, Tocopherols, Bisabolol.

Other Information

• protect this product from excessive heat and direct sun

Questions or Comments?

Call: 310-456-8787 www.goodtobebu.com

PRINCIPAL DISPLAY PANEL - 98 mL Bottle Label

SPF50
broad
spectrum

KiDS

spray-on
alcohol-free
performance
sunscreen

Oil-Free
Preservative-Free

with Antioxidants

Fragrance-Free

bü

Water Resistant (80 Minutes)

3.3oz (98mL)

INGREDIENTS AND APPEARANCE

BU SPF 50 KIDS BROAD SPECTRUM ALCOHOL-FREE PERFORMANCE SUNSCREEN - FRAGRANCE FREE 
octinoxate, octocrylene, octisalate, avobenzone, and homosalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70325-5002
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	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
OCTYLDODECANOL (UNII: 461N1O614Y)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70325-5002-3	98 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2016
2	NDC: 70325-5002-1	30 mL in 1 BOTTLE; 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(70325-5002)