Neutrogena ® Beach Defense ® water + sun protection sunscreen stick BROAD SPECTRUM SPF 50+

Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Stick Broad Spectrum SPF 50 Plus by

Drug Labeling and Warnings

Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Stick Broad Spectrum SPF 50 Plus by is a Otc medication manufactured, distributed, or labeled by Knowlton Development Corporation Inc, Knowlton Development Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION SUNSCREEN STICK BROAD SPECTRUM SPF 50 PLUS- avobenzone, homosalate, octisalate, and octocrylene spray 
Knowlton Development Corporation 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 ® Beach Defense ® water + sun protection sunscreen stick BROAD SPECTRUM SPF 50+

Drug Facts

Active ingredientsPurpose
Avobenzone 3%Sunscreen
Homosalate 15%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 10%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

  • apply liberally and evenly 15 minutes before sun exposure
  • ensure complete coverage to the area above the lip, nose and tops of ears
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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
  • After use, twist stick down prior to capping to ensure complete closure.

Other information

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

Inactive ingredients

Neopentyl Glycol Diethylhexanoate, Octyldodecyl Neopentanoate, Polyethylene, Isohexadecane, Butyloctyl Salicylate, Ozokerite, Paraffin, Synthetic Beeswax, C12-15 Alkyl Benzoate, VP/Eicosene Copolymer, Neopentyl Glycol Diisostearate, Dimethicone, Diethylhexyl 2,6-Naphthalate, Styrene/Acrylates Copolymer, Fragrance, BHT

Questions?

Call toll‐free 800-299-4786 or 215‐273‐8755 (collect). www.neutrogena.com

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 42 g Canister Label

Neutrogena ®
#1 DERMATOLOGIST RECOMMENDED BRAND
Beach
Defense ®
water + sun protection
sunscreen stick
BROAD SPECTRUM SPF 50+

50+
helioplex ®
broad spectrum uvauvb
water resistant (80minutes)
NET WT. 1.5 OZ. (42 g)

Principal Display Panel - 42 g Canister Label
NEUTROGENA BEACH DEFENSE WATER PLUS SUN PROTECTION SUNSCREEN STICK BROAD SPECTRUM SPF 50 PLUS 
avobenzone, homosalate, octisalate, and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54565-1627
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CERESIN (UNII: Q1LS2UJO3A)  
PARAFFIN (UNII: I9O0E3H2ZE)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54565-1627-142 g in 1 CANISTER; Type 0: Not a Combination Product10/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/07/2019
Labeler - Knowlton Development Corporation Inc (204006464)
Establishment
NameAddressID/FEIBusiness Operations
Knowlton Development Corporation204006464manufacture(54565-1627) , analysis(54565-1627) , pack(54565-1627) , label(54565-1627)

Revised: 10/2019
Document Id: 962570df-6e21-1dee-e053-2995a90a9efe
Set id: 9625700f-4de8-2821-e053-2995a90a3424
Version: 1
Effective Time: 20191030
 
Knowlton Development Corporation Inc