BOBBI BROWN BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octisalate, and octocrylene spray

BOBBI BROWN BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

BOBBI BROWN BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 2.0%
Octinoxate 5.0%
Octisalate 4.5%
Octocrylene 2.8%

Purpose

Sunscreen

Use

helps prevent sunburn

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.

Directions

For sunscreen use:

• spray generously and spread evenly by hand 15 minutes before sun exposure
• reapply at least every two hours and immediately after towel drying, and after 40 minutes of swimming or perspiring
• 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 value 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-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

olea europaea (olive) fruit oil octyldodecyl neopentanoate vitis vinifera (grape) seed oil caprylic/capric triglyceride pvp/hexadecene copolymer ricinus communis (castor) seed oil fragrance (parfum) cholesterol linoleic acid tocopheryl acetate bht hydroxycitronellal geraniol benzyl salicylate hexyl cinnamal amyl cinnamal linalool limonene citronellol benzyl benzoate cinnamyl alcohol farnesol citral phenoxyethanol <iln43472>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Carton

BOBBI BROWN
Beach

Sunscreen Body Spray
Broad Spectrum SPF 15

6.7 FL. OZ. LIQ./200 ml e

INGREDIENTS AND APPEARANCE

BOBBI BROWN BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, octisalate, and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0188 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.047 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0423 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.02632 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GRAPE SEED OIL (UNII: 930MLC8XGG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CASTOR OIL (UNII: D5340Y2I9G)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
GERANIOL (UNII: L837108USY)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BENZYL BENZOATE (UNII: N863NB338G)
CINNAMYL ALCOHOL (UNII: SS8YOP444F)
FARNESOL (UNII: EB41QIU6JL)
CITRAL (UNII: T7EU0O9VPP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-024-01	1 in 1 CARTON	01/01/2017
1		200 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2017

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(64141-024) , REPACK(64141-024)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-024)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-024)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-024)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-024)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(64141-024) , REPACK(64141-024)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(64141-024) , REPACK(64141-024)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-024)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-024)