NEUTROGENA® HEALTHY SKIN PRIMER BROAD SPECTRUM SPF 15

Neutrogena Healthy Skin Primer by

Drug Labeling and Warnings

Neutrogena Healthy Skin Primer by is a Otc medication manufactured, distributed, or labeled by Neutrogena Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NEUTROGENA HEALTHY SKIN PRIMER  BROAD SPECTRUM SPF15- avobenzone, homosalate, and octinoxate liquid 
Johnson & Johnson Consumer 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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NEUTROGENA® HEALTHY SKIN PRIMER BROAD SPECTRUM SPF 15

Drug Facts

Active ingredientsPurpose
Avobenzone (2%)Sunscreen
Homosalate (3%)Sunscreen
Octinoxate (4%)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 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 2 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

Other Information

  • protect this product from excessive heat and direct sun
  • may stain some fabrics

Inactive ingredients

Water, Dimethicone, C12-15 Alkyl Benzoate, Isododecane, Methyl Trimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Silica, Butylene Glycol, PEG-9 Polydimethylsiloxyethyl Dimethicone, Synthetic Fluorphlogopite, Dimethicone/PEG-10/15 Crosspolymer, Sodium Chloride, Nylon-12, Phenoxyethanol, Quaternium-90 Bentonite, Dimethicone Crosspolymer, Caprylyl Glycol, Glycine Soja (Soybean) Seed Extract, Tocopherol, Propylene Carbonate, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Sorbic Acid, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Titanium Dioxide, Mica, Bismuth Oxychloride, Iron Oxides, Tin Oxide

Questions or comments?

Visit www. Neutrogena.com or call toll-free 800-480-4812 or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL - 30 mL Tube Blister Pack

NEW

healthy skin
primer
with
sunscreen
broad spectrum SPF 15

Evens the look of
skin for 8 hours with
or without makeup
Extends the wear
of makeup

Neutrogena®

1 FL. OZ. (30 mL)

PRINCIPAL DISPLAY PANEL - 30 mL Tube Blister Pack
NEUTROGENA HEALTHY SKIN PRIMER   BROAD SPECTRUM SPF15
avobenzone, homosalate, and octinoxate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10812-608
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone20 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate30 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Isododecane (UNII: A8289P68Y2)  
Methyl Trimethicone (UNII: S73ZQI0GXM)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Butylene Glycol (UNII: 3XUS85K0RA)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
Sodium Chloride (UNII: 451W47IQ8X)  
Nylon-12 (UNII: 446U8J075B)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Soybean (UNII: L7HT8F1ZOD)  
Tocopherol (UNII: R0ZB2556P8)  
Propylene Carbonate (UNII: 8D08K3S51E)  
Edetate Disodium (UNII: 7FLD91C86K)  
Sorbic Acid (UNII: X045WJ989B)  
FEVERFEW (UNII: Z64FK7P217)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Mica (UNII: V8A1AW0880)  
Bismuth Oxychloride (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Stannic Oxide (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10812-608-011 in 1 BLISTER PACK03/26/201203/31/2020
130 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 10812-608-021 mL in 1 PACKET; Type 0: Not a Combination Product03/26/201203/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/26/201203/31/2020
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 12/2019
Document Id: 5a033b87-2041-421b-ad8f-103ddda566a4
Set id: f7711b4c-15af-4008-a58d-0c154529dae4
Version: 3
Effective Time: 20191213
 
Johnson & Johnson Consumer Inc.