PROTECTION 50 SPORT- homosalate, octocrylene, octisalate, and avobenzone lotion 
Dermalogica, LLC.

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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Protection 50 Sport

Drug Facts

Active ingredients

Avobenzone (3.0%)
Octisalate (5.0%)
Homosalate (10.0%)
Octocrylene (10.0%)

Purpose

Sunscreen

Uses

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

Other information

Inactive ingredients

Water/Aqua/Eau, Carthamus Tinctorius (Safflower) Oleosomes, Butylene Glycol, Dimethicone, Methyl Methacrylate Crosspolymer, C15-19 Alkane, VP/ Eicosene Copolymer, Silica, Dimethyl Capramide, Polyglyceryl-2 Stearate, Squalane, Dipotassium Glycyrrhizate, Arachidyl Glucoside, Glyceryl Stearate SE, PEG-100 Stearate, Arachidyl Alcohol, Potassium Cetyl Phosphate, Dimethicone Crosspolymer, Behenyl Alcohol, Xanthan Gum, Acrylates/C10- 30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Ethylhexylglycerin, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, Citric Acid, Phenoxyethanol.

Questions or comments

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 156 mL Tube Carton

protection
50
sport

SPF
50

broad spectrum

80 minutes
water-resistant

5.3 US FL OZ / 156 mL ℮

dermalogica

PRINCIPAL DISPLAY PANEL - 156 mL Tube Carton
PROTECTION 50 SPORT 
homosalate, octocrylene, octisalate, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-232
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 mg  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene10 mg  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 mg  in 100 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
Dimethicone (UNII: 92RU3N3Y1O)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
C15-19 Alkane (UNII: CI87N1IM01)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Dimethyl Capramide (UNII: O29Y6X2JEZ)  
Polyglyceryl-2 Stearate (UNII: 253MC0P0YV)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
PEG-100 Stearate (UNII: YD01N1999R)  
Glyceryl Stearate SE (UNII: FCZ5MH785I)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
Squalane (UNII: GW89575KF9)  
DOCOSANOL (UNII: 9G1OE216XY)  
Xanthan Gum (UNII: TTV12P4NEE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
Benzyl Alcohol (UNII: LKG8494WBH)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)  
Sodium Hydroxide (UNII: 55X04QC32I)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-232-021 in 1 CARTON08/05/2019
1156 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68479-232-002 mL in 1 POUCH; Type 0: Not a Combination Product08/05/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/05/2019
Labeler - Dermalogica, LLC. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
Cosway052400223MANUFACTURE(68479-232)

Revised: 7/2022
Document Id: a1838a21-18ab-4c11-a6c4-8dcff1d4cdc5
Set id: e9ace96a-7717-4f5a-8e1b-1f56f7498599
Version: 1
Effective Time: 20220708
 
Dermalogica, LLC.