Label: SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE- zinc oxide, octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69718-155-01, 69718-155-02, 69718-155-03, 69718-155-04 - Packager: Vitality Institute Medical Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 April 10, 2015
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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 or after towel drying, swimming or sweating
- Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including
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Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
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limit time in the sun, especially from 10am-2pm
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wear long-sleeved shirts, pants, hats, and sunglasses
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children under 6 months of age: Askj a doctor
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INACTIVE INGREDIENT
Inactive Ingredients
Water, C12-15, Alkyl Benzoate, Octyldodecly Neopentanoate, Polysorbate 60, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG - 100 Stearate, Coconut Alkanes, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Dimethicone, Aloe Barbadensis Leaf Extract, Citrus Grandis Fruit Extract, Anthemis Nobilis Flower Extract, Pueraria Lobata Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Benzyl Alcohol, Ehtylhexylglycerin, Phenoxyethanol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE
zinc oxide, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69718-155 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 10 g in 17.5 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 17.5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) POLYSORBATE 60 (UNII: CAL22UVI4M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Glycerin (UNII: PDC6A3C0OX) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) COCONUT ALKANES (UNII: 1E5KJY107T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) DIMETHICONE (UNII: 92RU3N3Y1O) ALOE VERA LEAF (UNII: ZY81Z83H0X) PUMMELO (UNII: ET1TN5W71X) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) GREEN TEA LEAF (UNII: W2ZU1RY8B0) EDETATE DISODIUM (UNII: 7FLD91C86K) XANTHAN GUM (UNII: TTV12P4NEE) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) BENZYL ALCOHOL (UNII: LKG8494WBH) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69718-155-02 1 in 1 BOX 1 NDC:69718-155-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69718-155-04 1 in 1 BOX 2 NDC:69718-155-03 59 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/26/2015 Labeler - Vitality Institute Medical Products (056496844) Registrant - VEGE-KURL, INC (021072509) Establishment Name Address ID/FEI Business Operations VEGE-KURL, INC 021072509 manufacture(69718-155)