NDC | 70581-006-01 |
Set ID | fe6ac9ab-7f9f-4798-837c-68ca7f4df5b1 |
Category | HUMAN OTC DRUG LABEL |
Packager | BPS 60 |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Drug Facts
- Active ingredient
- uses
- Warnings
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Directions
For sunscreen use: •shake well • apply liberally 15 minutes before sun exposure • reaply at least every 2 hours • use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk. regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun. especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: Ask a doctor - Other information
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Inactive ingredients
water, cyclohexasiloxane,alcohol denat., isododecane,butylene glycol, acrylates/polytrimethylsiloxymethacrylate copolymer, nylon-12, PEG-10 simethicone, isohexadecane, silica, perlite,alumiunu hydroxide, magnesium sulfate, disodium stearoyl glutamate, cetyl PEG/PPG-101-1 dimethicone; may contain: titanium dioxide, Iron oxides.
- Questions or comments?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
TEINT IDOLE ULTRA 24H MAKEUP OCTINOXATE SUNSCREEN BROAD SPECTRUM SPF 15
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70581-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) ALCOHOL (UNII: 3K9958V90M) ISODODECANE (UNII: A8289P68Y2) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NYLON-12 (UNII: 446U8J075B) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOHEXADECANE (UNII: 918X1OUF1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70581-006-01 1 in 1 BOX 04/07/2016 1 110 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/07/2016 Labeler - BPS 60 (272259304) Establishment Name Address ID/FEI Business Operations BPS 60 272259304 pack(70581-006)