Label: BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50- avobenzone,homosalate,octisalate,octocrylene,and oxybenzone cream
- NDC Code(s): 64141-035-01
- Packager: Bobbi Brown Professional Cosmetics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 18, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warnings
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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 sunglasseschildren 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50
avobenzone,homosalate,octisalate,octocrylene,and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 50 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-035-01 1 in 1 CARTON 08/18/2023 1 40 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 08/18/2023 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(64141-035)
