DT COLLAGEN- octocrylene cream 
DT Collagen, 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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DT Collagen

Octocrylane 10%, Homosalate 10%, Octinoxate 7.5%, Octinoxate 5%, Avobenzone 3.5%

Sunscreen

Helps prevent sunburn

For external use only.

Do not use on damaged or borken skin.

When using this product: keep out of eyes, rinse eyes with water to remove, stop use and ask a doctor if rash occurs.

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

Keep out of reach of children.

Directions

Apply liberally 15 minutes before sun exposure.

Reapply: after 80 minutes of swimming or sweating, immediatly after towel drying, at least every 2 hours.

Children under 6 months ask a doctor.

Other information

Do not store in excessive heat or direct sunlight.

Aqua, vinyl dimethicone copolymer, shea butter, C13-14 isoparafin, caprylic/capric triglyceride, ceramide2, cetearyl alcohol, cetyl alcohol, cyclomethicone, dimethicone, di=panthenol, ethylhexyl palimitate, ethylhexylglycerin, glycerin, glyceryl stearate, hyaluronic acid, laureth-7, PEG-100, stearate, phenoxyethanol, polyacrylamide, polosorbate 20, propyleneylycol, soluble collagen, tocopheryl acetate, triethanolamine

DT collagen

DT COLLAGEN 
octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70522-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE 100 (UNII: RO266O364U)  
PANTHENOL (UNII: WV9CM0O67Z)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
HYALURONIC ACID (UNII: S270N0TRQY)  
LAURETH-7 (UNII: Z95S6G8201)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.ALPHA.-TOCOTRIENOL (UNII: B6LXL1832Y)  
TRIETHANOLAMINE OLEATE (UNII: DZ7P3IE35F)  
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
CERAMIDE 2 (UNII: C04977SRJ5)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PROPYLENE GLYCOL 2-OLEATE (UNII: R3FST8K0ZL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70522-001-0150 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2016
Labeler - DT Collagen, Inc. (011478279)
Registrant - DT Collagen (011478279)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source080354456manufacture(70522-001)

Revised: 12/2017
Document Id: 6067f927-ac01-500b-e053-2a91aa0ae1cf
Set id: 2883b764-0d58-57ad-e054-00144ff88e88
Version: 2
Effective Time: 20171215
 
DT Collagen, Inc.