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NDC 70325-5003-01 bu SPF 50 S Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage Scent 3; 7.5; 7.5; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Details

bu SPF 50 S Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage Scent 3; 7.5; 7.5; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL

bu SPF 50 S Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage Scent is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Bu Brands, LLC. The primary component is AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	70325-5003
Product ID	70325-5003_99a841bc-60c6-4150-ac36-8b604277fa77
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	bu SPF 50 S Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage Scent
Proprietary Name Suffix	n/a
Non-Proprietary Name	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, and HOMOSALATE
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	3; 7.5; 7.5; 5; 10
Active Ingredient Units	g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Bu Brands, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70325-5003-01 (70325500301)

Pricing Information	N/A
NDC Package Code	70325-5003-1
Billing NDC	70325500301
Package	30 mL in 1 BOTTLE (70325-5003-1)
Marketing Start Date	2016-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b4127373-9f93-45c2-9777-be8b7ca37a9a Details

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, Lavendula Angustifolia Oil, Citrus Aurantium Bergamia (Bergamot) Fruit, Salvia Officinalis (Sage) Oil and Santalum Album (Sandlewood) Oil.

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

spray-on

alcohol-free

performance

sunscreen

Oil-Free

Preservative-Free

with Antioxidants

Natural White Sage

Scent

bü

Water Resistant (80 Minutes)

3.3oz (98mL)

PRINCIPAL DISPLAY PANEL - 98 mL Bottle Label

INGREDIENTS AND APPEARANCE

BU SPF 50 S BROAD SPECTRUM ALCOHOL-FREE PERFORMANCE SUNSCREEN - NATURAL WHITE SAGE SCENT

octinoxate, octocrylene, octisalate, avobenzone, and homosalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70325-5003
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	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

Ingredient Name	Strength
Inactive Ingredients
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)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SAGE OIL (UNII: U27K0H1H2O)
SANDALWOOD OIL (UNII: X7X01WMQ5F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70325-5003-3	98 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2016
2	NDC:70325-5003-1	30 mL in 1 BOTTLE; 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(70325-5003)

Revised: 1/2021

Document Id: 99a841bc-60c6-4150-ac36-8b604277fa77

Set id: b4127373-9f93-45c2-9777-be8b7ca37a9a

Version: 3

Effective Time: 20210119