Label: CONCEALER BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70698-004-01 - Packager: Epione Medical Corporation
- 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 July 3, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions:
Apply evenly 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children Under 6 months: Ask a doctor.Sun Protection Measures:
Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10a.m.-2p.m.
Wear long-sleeved shirt, pants, hats, and sunglasses
Reapply at least every 2 hours -
INACTIVE INGREDIENT
Water, Coconut Alkanes, Octyldodecyl Neopentanoate, Butylene Glycol, C12-15 Alkyl Benzoate, Polysorbate 60, Cyclopentasiloxane, Dimethicone, Cetearyl Alcohol, Glycerine, Polysorbate 60, Polyacrylamide, Polyhydroxystearic Acid, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, C13-14 Isoparaffin, Coco-Caprylate/Caprate, Stearic Acid, Acrylates/C10-30 Alklyl Acrylates Crosspolymer, Ethylhexylglycerin, Alumina, Xanthan Gum, Laureth-7, Triethanolamine, Iron Oxides( CI 77499, CI 77491, CI77492).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CONCEALER BROAD SPECTRUM SUNSCREEN SPF 30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70698-004 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 OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCONUT ALKANES (UNII: 1E5KJY107T) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) XANTHAN GUM (UNII: TTV12P4NEE) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LAURETH-7 (UNII: Z95S6G8201) FERRIC OXIDE RED (UNII: 1K09F3G675) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYSORBATE 60 (UNII: CAL22UVI4M) DIMETHICONE (UNII: 92RU3N3Y1O) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70698-004-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/05/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/05/2018 Labeler - Epione Medical Corporation (088809509) Establishment Name Address ID/FEI Business Operations VEGE-KURL, INC 021072509 manufacture(70698-004)
