NDC | 64990-885-01 |
Set ID | 4ef6146c-4f3d-498f-8b73-f605131f6054 |
Category | HUMAN OTC DRUG LABEL |
Packager | Isomers Laboratories Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Enter section text here
Inactive Ingredients:
Purified Water, Cetearyl Alcohol, Phenyl Trimethicone, Caprylic/Capric Triglyceride, Propylen Glycol, Ceteareth-20, Polyhydroxystearic Acid, Mineral Oil, Panthenol, Silica, PVP, Chlorphenesin, Tocopheryl Acetate, Aloe Barbadensis Leaf extract, Polysorbate 60, BHT, Phenoxyethanol, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben.
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DOSAGE & ADMINISTRATION
- Apply Liberally 15 minutes before sun exposure.
- reapply at least every two hours
- use a water -resistant sunscreen if swimming or sweating
- children under 6 months of age: Ask a doctor.
- Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease this risk, regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures.
- Limit time in the sun especially from 10 a.m. to 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN WITH UV PEARLS BROAD SPECTRM SPF 20
zinc oxide, octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64990-885 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc Oxide 80 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cetostearyl Alcohol (UNII: 2DMT128M1S) Polysorbate 60 (UNII: CAL22UVI4M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Silicon Dioxide (UNII: ETJ7Z6XBU4) Chlorphenesin (UNII: I670DAL4SZ) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Aloe Vera Leaf (UNII: ZY81Z83H0X) Panthenol (UNII: WV9CM0O67Z) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Phenyl Trimethicone (UNII: DR0K5NOJ4R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MINERAL OIL (UNII: T5L8T28FGP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) UREA (UNII: 8W8T17847W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64990-885-01 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/06/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/31/2003 Labeler - Isomers Laboratories Inc (253306799) Registrant - Isomers Laboratories Inc (253306799) Establishment Name Address ID/FEI Business Operations Isomers laboratories Inc 253306799 manufacture(64990-885)