NDC | 36800-723-05, 36800-723-06 |
Set ID | 298b2aa5-de4a-4507-a304-6e63dbb957f9 |
Category | HUMAN OTC DRUG LABEL |
Packager | TopCare |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3%.......................................................................................Sunscreen
Homosalate 10%.....................................................................................Sunscreen
Octisalate 5%..........................................................................................Sunscreen
Octocrylene 4%.......................................................................................Sunscreen
Oxybenzone 5%.......................................................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Flammable: Do not use near heat, flame, or while smoking.
For external use only
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if • rash or irritation develops and lastAvoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do
not store at temperature above 120°F - KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions • Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor. • 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, 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. • Hold container 4 to 6 inches
from the skin to apply. • Do not spray directly into face. Spray on hands then apply
to face. • Do not apply in windy conditions. • Use in a well-ventilated area. • For
sunscreen use: • apply to all skin exposed to the sun. • Reapply as needed or after
towel drying, swimming, or sweating. - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIDS SPF 50
avobenzone 3% homosalate 10% octisalate 5% octocrylene 4% oxybenzone 5% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-723 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 10 g in 100 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 4 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248) Glycerin (UNII: PDC6A3C0OX) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-723-05 170 g in 1 CAN; Type 0: Not a Combination Product 02/15/2016 2 NDC:36800-723-06 227 g in 1 CAN; Type 0: Not a Combination Product 02/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/15/2016 Labeler - TopCare (006935977) Registrant - Product Quest (927768135) Establishment Name Address ID/FEI Business Operations Product Quest 927768135 manufacture(36800-723) , label(36800-723)