TINTED MOISTURIZER SPF 20- zinc oxide titanium dioxide cream

Tinted Moisturizer SPF 20 by

Drug Labeling and Warnings

Tinted Moisturizer SPF 20 by is a Otc medication manufactured, distributed, or labeled by Kamins Dermatologics Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

Zinc Oxide 7.5%

Titanium Dioxide 4.4%

PURPOSE

Purpose: Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

This cream is enriched with moisturizing acai oil to help skin remain hydrated while adding a touch of color and glow to your skin.

Uses

■ Helps prevent sunburn.

■ Higher SPF gives more sunburn protection.

■ Provides moderate protection against sunburn.

WARNINGS

Warnings

■ For external use only.

■ When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

■ Stop use and ask a doctor if rash or irritation develops and lasts.

■ If swallowed, seek medical assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

■ Apply in the morning and prior to sun exposure. Reapply as needed.

■ Children under 6 months of ask: ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients: Aqua/Water/Eau, Caprylic/Capric Triglyceride, Oleyl Oleate, Polyglyceryl-2 Dipolyhydroxystearate, Pentaerythrityl Tetraisostearate, Butylene Glycol, Cyclopentasiloxane, PEG/PPG-20/15 Dimethicone, Triethoxycaprylylsilane, Sodium Lauryl Glucose Carboxylate, Lauryl Glucoside, Glycerin, Xanthan gum, Magnesium Aluminum Silicate, Acai Fruit Oil, Citric Acid, Isononyl Isononanoate, Isopropyl Titanium Triisostearate, Synthetic Wax, Caprylyl Glycol, Phenoxyethanol, Sorbic Acid, Iron oxides (CI 77491, 77492).

PRINCIPAL DISPLAY PANEL

B. KAMINS

TINTED MOISTURIZER SPF15

50mL / 1.7 fl.oz

NPN 80026968

image/jpg

INGREDIENTS AND APPEARANCE

TINTED MOISTURIZER SPF 20 
zinc oxide titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63550-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	44 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ACAI OIL (UNII: Z0W6766A2W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
WHITE WAX (UNII: 7G1J5DA97F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63550-158-03	50 mL in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/31/2011

Labeler - Kamins Dermatologics Inc. (254050784)

Registrant - Kamins Dermatologics Inc. (254050784)

Establishment
Name	Address	ID/FEI	Business Operations
Kamins Dermatologics Inc.		254050784	manufacture, pack, label