Label: KIDS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick
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Contains inactivated NDC Code(s)
NDC Code(s): 11344-791-84 - Packager: Vi-Jon
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 24, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- claims
- Active ingredients
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use section if
- Keep out of reach of children
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Directions
- 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, regularly use a sunscreen with a Broad Spectrum SPF value or 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
- inactive ingredients
- disclaimer
- Disclaimer
- principal display panel
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INGREDIENTS AND APPEARANCE
KIDS SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11344-791 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) homosalate 150 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) octocrylene 100 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) LAURYL LAURATE (UNII: GPW77G0937) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) CETYL ALCOHOL (UNII: 936JST6JCN) CERESIN (UNII: Q1LS2UJO3A) CETEARYL BEHENATE (UNII: 7ARI9LTH0U) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) TOCOPHEROL (UNII: R0ZB2556P8) COCOA BUTTER (UNII: 512OYT1CRR) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PHENOXYETHANOL (UNII: HIE492ZZ3T) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11344-791-84 1 in 1 BLISTER PACK 07/01/2017 1 17 g in 1 APPLICATOR; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/01/2017 Labeler - Vi-Jon (150931459) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 088520668 manufacture(11344-791)
