DERMADOCTOR DD EYE SPF30- zinc oxide, titanium dioxide cream

DermaDoctor DD Eye by

Drug Labeling and Warnings

DermaDoctor DD Eye by is a Otc medication manufactured, distributed, or labeled by DERMAdoctor. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 3%

Zinc Oxide 7%

Purpose

Sunscreen

Uses

•    helps prevent sunburn if used as directed with other sun protection measures (see​Directions​)
•    decreases the risk of skin cancer and early skin aging caused by the sun

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 product is swallowed, get medical help or contact a Poinson Control Center right away

Directions

• apply 360 degrees around the eyes twice daily
• apply lierally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• do not use on children under 6 months.
• Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin aging.   To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other protection measures including
•  limit time in the sun,especially from 10 a.m.-2 p.m.
• wear long sleeved shirts, pants, hats and sunglasses
• reapply at least every 2 hours.

Inactive Ingredients

Albizia Julibrissin Bark Extract, Aloe Barbadensis Leaf Juice, Alumina, Aminomethyl Propanol, Argania Spinosa Kernel Oil, Bisabolol, C12-15 Alkyl Benzoate, Caffeine, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cellulose Gum, Ceramide NG, Cetearyl Alcohol, Citric Acid, Coco-Caprylate, Cocos Nucifera (Coconut) Oil, Darutoside, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Isostearic Acid, Jojoba Esters, Lauryl Glucoside, Lecithin, Mica, Microcrystalline Cellulose,
Palmitoyl Hexapeptide-12, Phenoxyethanol, Phytic Acid, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Sodium Stearoyl Lactylate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Water, Xanthan Gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMADOCTOR DD EYE  SPF30
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68715-367
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7 g  in 100.0 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 g  in 100.0 mL

Inactive Ingredients
Ingredient Name	Strength
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
ALUMINUM OXIDE (UNII: LMI26O6933)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
LEVOMENOL (UNII: 24WE03BX2T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAFFEINE (UNII: 3G6A5W338E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CERAMIDE NG (UNII: C04977SRJ5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO-CAPRYLATE (UNII: 4828G836N6)
COCONUT OIL (UNII: Q9L0O73W7L)
DARUTOSIDE (UNII: EG8ODI0780)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ISOSTEARIC ACID (UNII: X33R8U0062)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FYTIC ACID (UNII: 7IGF0S7R8I)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
water (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68715-367-02	1 in 1 CARTON	12/01/2018
1	NDC: 68715-367-01	15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2018

Labeler - DERMAdoctor (114399392)