ULTRA SHADE SUNSCREEN SPF 30 TAHERI MD- titanium dioxide, zinc oxide cream

Ultra Shade Sunscreen SPF 30 by

Drug Labeling and Warnings

Ultra Shade Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by LA LASER CENTE, PC, CALIFORNIA PROFESSIONAL MEDICAL CORP, VEGE-KURL, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                     Purpose

Titanium Dioxide 5.00%              Sunscreen

Zinc Oxid 10.00%

PURPOSE

Uses

• Helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

- For external use only. 

- Do not use on damage or broken skin.

- Whenn using this product keep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION

Directions

• Apply generously 15 minutes before sun exposure
• Reapply:

-after 80 minutes of swimming or sweating

-immediatley after towel drying

- at least every 2 hours

• Chirldren under 6 months of age: ask a doctor

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Alumina, Aqua, Butylene Glycol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Cetearyl Alcohol,

Coco-Caprylate/Caprate, Coconut Alkanes, Cyclopentasiloxane, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Iron Oxides, Laureth-7, Octoyldodecyl Neopentanoate, Polyhydroxystearic Acid, Triethanolamine, Xanthan Gum 

PRINCIPAL DISPLAY PANEL

TAHERI MD

Ultra Shade Sunscreen SPF 30

Non- Comedogenic

1.7 0z / 50 ml

INGREDIENTS AND APPEARANCE

ULTRA SHADE SUNSCREEN SPF 30  TAHERI MD
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70919-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALUMINUM OXIDE (UNII: LMI26O6933)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
COCONUT ALKANES (UNII: 1E5KJY107T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LAURETH-7 (UNII: Z95S6G8201)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70919-001-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/17/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/17/2016

Labeler - LA LASER CENTE, PC, CALIFORNIA PROFESSIONAL MEDICAL CORP (080323225)

Registrant - LA LASER CENTE, PC, CALIFORNIA PROFESSIONAL MEDICAL CORP (080323225)

Establishment
Name	Address	ID/FEI	Business Operations
VEGE-KURL, INC		021072509	manufacture(70919-001)