Label: ULTRA SHADE SUNSCREEN SPF 30 TAHERI MD- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70919-001-01 - Packager: LA LASER CENTE, PC, CALIFORNIA PROFESSIONAL MEDICAL CORP
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 3, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
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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
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INGREDIENTS AND APPEARANCE
ULTRA SHADE SUNSCREEN SPF 30 TAHERI MD
titanium dioxide, zinc oxide creamProduct 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)
