SUN DEFEATED SUNSCREEN - avobenzone, octocrylene, oxybenzone, octisalate lotion 
Mission

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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Drug Facts

Active Ingredients:                                                               Purpose:

Avobenzone (3.0%)..............................................................Sunscreen

Octocrylene (7.0%)...............................................................Sunscreen

Oxybenzone (4.0%)...............................................................Sunscreen

Octisalate (8.0%)...................................................................Sunscreen

Warnings: FOR EXTERNAL USE ONLY

UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using sunscreen.

Directions:  Apply liberally before sun exposure. Apply and reapply, as directed to avoid lowering protection. Reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise reapply at least every two hours. Children under 6 months: ask a doctor.

Aqua (Deionized Water), Glyceryl Stearate, Isopropyl Palmitate, Stearic Acid, PEG 100 Stearate, C 12-15 Alkyl Benzoate, Acrylates/C12-22 Alkylmethacrylates Copolymer, Sorbitol, Marshmallow Extract, Ivy Extract, Cucumber Extract, Elder Flower, Arnica Extract, Tocopheryl Acetate, Acrylates Copolymer, Cetyl Alcohol, Dimethicone, VP/Hexadecene Copolymer, Aloe Barbadenis Leaf Juice, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, EDTA, Phenoxyethanol, Ethylhexylglycerin

image of tube label

image of tube box

SUN DEFEATED SUNSCREEN 
avobenzone, octocrylene, oxybenzone, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51702-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2.79 g  in 93 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene6.51 g  in 93 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone3.74 g  in 93 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate7.44 g  in 93 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
SORBITOL (UNII: 506T60A25R)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
CUCUMBER JUICE (UNII: 61845009SP)  
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
ARNICA MONTANA (UNII: O80TY208ZW)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETIC ACID (UNII: 9G34HU7RV0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51702-114-021 in 1 BOX
1NDC:51702-114-0193 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/12/2012
Labeler - Mission (831230425)

Revised: 3/2012
Document Id: 178df289-8507-479d-9354-6cb3e8f47f61
Set id: 08a9dd7f-ca0d-46e2-a8d9-8f0ad201ee28
Version: 1
Effective Time: 20120312
 
Mission