AQUA PROTECTION SUNSCREEN BROAD SPECTRUM SPF50- avobenzone, homosalate, octisalate, octocrylene lotion 
ENGLEWOOD LAB, INC.

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Aqua protection Sunscreen Broad Spectrum SPF50+

Drug Facts

Active Ingredients

Avobenzone, 3.0%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene, 5.0%

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

ir rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Othe information

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

Inactive ingredients

Water (Aqua), Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Glyceryl Polymethacrylate, Propylene Glycol, Butyloctyl Salicylate, Ceteareth-20, Ethylhexyl Methoxycrylene, Acrylates Copolymer, Polysorbate 60, Sorbitan Stearate, Caprylyl Glycol, Cetearyl Olivate, Panthenol, Sorbitan Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tromethamine, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, 1,2-Hexanediol, Isohexadecane, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Musa Sapientum Flower Extract, Rosa Damascena Flower Water, Pyrus Communis (Pear) Fruit Extract, Bht, Prunus Domestica Fruit Extract, Polysorbate 80, Cucumis Melo (Melon) Fruit Extract, Trisodium Ethylenediamine Disuccinate, Hedera Helix (Ivy) Leaf/Stem Extract, Xanthan Gum, Butylene Glycol, Glucosylrutin, Equisetum Arvense Extract, Lycopodium Clavatum Extract, Sodium Hyaluronate, Polyglutamic Acid, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Betula Platyphylla Japonica Juice, Pentylene Glycol

Package Labeling:

Outer LabelInner Label

AQUA PROTECTION SUNSCREEN BROAD SPECTRUM SPF50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14268-122
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
PANTHENOL (UNII: WV9CM0O67Z)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SODIUM ACRYLATE (UNII: 7C98FKB43H)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
PEAR (UNII: 2ZN8DWC0YF)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PLUM (UNII: 67M3EQ6BE1)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
MUSKMELON (UNII: ZV095H5633)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HYALURONIC ACID (UNII: S270N0TRQY)  
BETULA PLATYPHYLLA RESIN (UNII: 1B33PG6N4K)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14268-122-0150 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/01/2023
Labeler - ENGLEWOOD LAB, INC. (172198223)

Revised: 12/2023
Document Id: 0c5b2855-6f2f-280e-e063-6394a90acadb
Set id: 627e6ea5-016b-4ab6-a50c-aa9c27e5cca1
Version: 6
Effective Time: 20231212
 
ENGLEWOOD LAB, INC.