NDC | 69718-155-01, 69718-155-02, 69718-155-03, 69718-155-04 |
Set ID | 507c46c3-3fd8-491e-850c-3060c7f488cd |
Category | HUMAN OTC DRUG LABEL |
Packager | Vitality Institute Medical Products |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
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:
-
limit time in the sun, especially from 10am-2pm
-
wear long-sleeved shirts, pants, hats, and sunglasses
-
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)