NDC | 36800-736-01 |
Set ID | 775ac769-d1ab-4e0b-88a4-b64a2d805b11 |
Category | HUMAN OTC DRUG LABEL |
Packager | Top Care |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
Remove cap and twist up tube.
See important warnings under "When using this
product" • apply liberally 15 minutes before sun
exposure • reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in
the sun increases your risk of skin cancer and
early skin aging. To decrease this risk,egularly 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 10 a.m. – 2 p.m. • wear
long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor - INACTIVE INGREDIENT
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ULTIMATE SHEER SPF 70
avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 3% stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-736 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 3 g in 100 g Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 15 g in 100 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 10 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 3 g in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Caprylyl Glycol (UNII: 00YIU5438U) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) Neopentyl Glycol Diisostearate (UNII: 4M6OQ34JWW) Octyldodecyl Neopentanoate (UNII: X8725R883T) CERESIN (UNII: Q1LS2UJO3A) Paraffin (UNII: I9O0E3H2ZE) Petrolatum (UNII: 4T6H12BN9U) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-736-01 43 g in 1 PACKAGE; Type 0: Not a Combination Product 02/23/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/23/2016 Labeler - Top Care (006935977) Registrant - Product Quiest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quiest Mfg 927768135 manufacture(36800-736) , label(36800-736)