DT COLLAGEN- octocrylene cream

DT Collagen by

Drug Labeling and Warnings

DT Collagen by is a Otc medication manufactured, distributed, or labeled by DT Collagen, Inc., DT Collagen, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

WARNINGS

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

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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DT COLLAGEN 
octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70522-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70522-001-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2016

Labeler - DT Collagen, Inc. (011478279)

Registrant - DT Collagen (011478279)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		080354456	manufacture(70522-001)