TINTED MOISTURIZER SPF 20 - zinc oxide titanium dioxide cream 
Kamins Dermatologics 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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Tinted Moisturizer SPF 20 CONSUMER LABELING

Active ingredients:

Zinc Oxide 7.5%

Titanium Dioxide 4.4%

Purpose: Sunscreen

Keep out of reach of children.

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

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.

Directions

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

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

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).

B. KAMINS

TINTED MOISTURIZER SPF15

50mL / 1.7 fl.oz

NPN 80026968

image/jpg

Tinted Moisturizer front panel image

TINTED MOISTURIZER SPF 20 
zinc oxide titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-158
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE44 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63550-158-0350 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/31/2011
Labeler - Kamins Dermatologics Inc. (254050784)
Registrant - Kamins Dermatologics Inc. (254050784)
Establishment
NameAddressID/FEIBusiness Operations
Kamins Dermatologics Inc.254050784manufacture, pack, label

Revised: 8/2011
Document Id: 08ec1173-8886-4703-9792-5e957d6c1608
Set id: 607fd485-f1c5-469c-a15b-9c0896114b1d
Version: 1
Effective Time: 20110831
 
Kamins Dermatologics Inc.