KIDS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

Kids Sunscreen by

Drug Labeling and Warnings

Kids Sunscreen by is a Otc medication manufactured, distributed, or labeled by Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

claims

SOLAR SCREEN

KIDS SUNSCREEN STICK SPF 55

Broad Spectrum SPF 55

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Oxybenzone 6%

Purpose

Sunscreen

Use

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the riskof skin cancer and early skin aging caused by the sun

Warnings

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 section if

• rash occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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

• protect the product from excessive heat and direct sun

inactive ingredients

beeswax, lauryl laurate, polybutene, cetyl alcohol, ozokerite, cetearyl behenate, myristyl myristate, styrene/acrylates copolymer, tocopherol, Theobroma cacao (cocoa) seed butter, retinyl palmitate, phenoxyethanol, tetrahexyldecyl ascorbate

disclaimer

May stain or damage some fabrics or surfaces

this product is not manufactured or distributed by Bayer distributor of Coppertone Kids Sunscreen Stick Broad Spectrum SPF 55

Disclaimer

Distributed by: Vi-Jon, Inc.
8515 Page Ave.
St. Louis, MO 63114
791.000/791AA

principal display panel

SPF 55

 SOLAR SCREEN

KIDS

SUNSCREEN

STICK SPF 55

Broad Spectrum

SPF 55

Water Resistant

(80 minutes)

Pediatrician Tested

PABA Free

Compare to

Coppertone

NET WT

0.6 OZ (17g)

INGREDIENTS AND APPEARANCE

KIDS SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

Product 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)