DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30 cream

DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30 by

Drug Labeling and Warnings

DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by MANA Products, INC., MANA PRODUCTS, INC., MANA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Titanium Dioxide 3.30%

Zinc Oxide 12.05%

USE

• 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.

DIRECTIONS

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use water resistant sunscreen if swimming or sweathing
• Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun especially from 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
• Children under 6 months: ask a doctor

INACTIVE INGREDIENTS

Alumina, Aluminum Hydroxide, Behenyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric/Myristic/Stearic Triglyceride, Caprylyl Glycol, Carbomer, Cellulose Gum, Cety Alcohol, Dextrin Palmitate, Dimethicone, Dimethylacrylamide/Acrylic Acid/Plystyrene Ethyl Methacylate, Disodium EDTA, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrogenated Lecithin, Isostearic Acid, Lycium Barbarum Fruit Extract, Lysine, Magnesium Chloride, Nordihydroguaiaretic Acid, Octyldodecyl Neopenanoate, Oleanolic Acid, Palmitoyl Hexapeptide-14, Panthenol, PEG-60 Almond Glycerides, Phenoxyethanol, Phospholipids, Phytantriol, Polygleceryl-3 Diisostearate, Polysorbate 80, Potassium Chloride, Silica, Sodium Benozate, Sodium Chloride, Sodium Dehydroacetate, Sodium Hyaluronate Crosspolymer, Sodium Hydroxide, Squalane, Steareth-2, Steareth-21, Stearic Acid, Superoxide Dismutase, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethylhexanoin, Water, Xanthan Gum, Zinc Chloride May Contain (+/-): Mica, Iron Oxides.

OTHER INFORMATION

• Protect this product form excessive heat and direct sun

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30 
dd cream dermatologically defining bb cream broad spectrum spf 30 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-565
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.3 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
2,3-DIMETHYLACRYLIC ACID, (E)- (UNII: I5792N03HC)
ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LYSINE (UNII: K3Z4F929H6)
NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON (UNII: Z4152N8IUI)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUPEROXIDE DISMUTASE (CU-ZN) SACCHAROMYCES CEREVISIAE (UNII: ZQP6EKT6WD)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
XANTHAN GUM (UNII: TTV12P4NEE)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE (UNII: ZF29F7IK5I)
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
PHYTANTRIOL (UNII: 8LVI07A72W)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOSTEARIC ACID (UNII: X33R8U0062)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM (UNII: CPD4NFA903)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER 940 (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-565-01	1 in 1 CARTON	12/12/2016
1		40 g 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 Drug	M020	12/12/2016

Labeler - MANA Products, INC. (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		032870270	manufacture(59735-565)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC.		078870292	manufacture(59735-565)