NDC | 47124-116-05, 47124-116-10 |
Set ID | 0c596b1d-8c23-4598-8b6f-95e1679069b9 |
Category | HUMAN OTC DRUG LABEL |
Packager | Wegman |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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Active ingredients Purpose
Avobenzone 3%..................................................................................Sunscreen
Homosalate 15%.................................................................................Sunscreen
Octisalate 5%......................................................................................Sunscreen
Octocrylene 10%.................................................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
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WarningsFor external use only
Flammable: Do not use near heat, flme, or while smoking.
Do not use on damaged or broken skin
When using this product • Keep out of eyes. Rinse eyes with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away. -
DOSAGE & ADMINISTRATION
Directions • spray liberally and spread evenly by hand 15 minutes before sun
exposure • reapply: • after 80 minutes of swimming or sweating • immediately after
towel drying • at least every 2 hours • 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
• 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 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
KIDS SUNSCREEN SPF 50
avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47124-116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 3.0 in 100 g Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 15.0 in 100 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5.0 in 100 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 10.0 in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248) Glycerin (UNII: PDC6A3C0OX) Stearoxytrimethylsilane (UNII: 9862TW94B2) Tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47124-116-10 340 g in 1 CAN; Type 0: Not a Combination Product 05/18/2018 2 NDC:47124-116-05 170 g in 1 CAN; Type 0: Not a Combination Product 05/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/18/2018 Labeler - Wegman (059650069) Registrant - Product Quest Mfg, LLC (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 manufacture(47124-116) , label(47124-116)