BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50- avobenzone,homosalate,octisalate,octocrylene,and oxybenzone cream 
Bobbi Brown Professional Cosmetics Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50

Active Ingredients

Avobenzone 3.00%

Homosalate 5.00%

Octisalate 5.00%

Octocrylene 2.70%

Oxybenzone 3.00%

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:

apply liberally 15 minutes before sun exposure
reapply at least every two hours
use a water resistant sunscreen if swimming or sweating
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

WATER\AQUA\EAU,BUTYLOCTYL SALICYLATE,METHYL TRIMETHICONE,NEOPENTYL GLYCOL DIHEPTANOATE,ALEURITES MOLUCCANA (KUKUI) SEED OIL,LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE,PEG-100 STEARATE,BUTYLENE GLYCOL,GLYCERYL STEARATE,DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE,LAMINARIA OCHROLEUCA EXTRACT,LAMINARIA DIGITATA EXTRACT,ALGAE EXTRACT,LAVANDULA ANGUSTIFOLIA (LAVENDER),PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL,SODIUM HYALURONATE,CAFFEINE,ERGOTHIONEINE,SORBITOL,ETHYLHEXYLGLYCERIN,POTASSIUM CETYL PHOSPHATE,CETYL ALCOHOL,VP/EICOSENE COPOLYMER,SACCHARIDE ISOMERATE,CAPRYLIC/CAPRIC TRIGLYCERIDE,CAPRYLYL GLYCOL,AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER,STEARIC ACID,DEHYDROXANTHAN GUM,SODIUM DEHYDROACETATE,DISODIUM EDTA,PHENOXYETHANOL,CITRIC ACID,CITRONELLOL,GERANIOL,LINALOOL,MICA <ILN39524>

Other Information

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

BOBBI
BROWN

Primer Plus Protection
BROAD
SPECTRUM
SPF 50

1.4 FL. OZ/40 ML e

Principal Display Panel

BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50 
avobenzone,homosalate,octisalate,octocrylene,and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MICA (UNII: V8A1AW0880)  
WATER (UNII: 059QF0KO0R)  
GERANIOL (UNII: L837108USY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)  
CAFFEINE (UNII: 3G6A5W338E)  
SORBITOL (UNII: 506T60A25R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64141-035-011 in 1 CARTON08/18/2023
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/18/2023
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
The Estee Lauder Inc802599436manufacture(64141-035)

Revised: 8/2023
Document Id: 03372376-ef04-943d-e063-6394a90a52ee
Set id: 03372376-ef03-943d-e063-6394a90a52ee
Version: 1
Effective Time: 20230818
 
Bobbi Brown Professional Cosmetics Inc.