Publix Kids (Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone) Spray [Publix Super Markets Inc] -

PUBLIX KIDS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PUBLIX SUPER MARKETS INC]
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NDC	56062-706-16
Set ID	5cfd7a7e-ce9d-40de-9424-6b0c653dc1b7
Category	HUMAN OTC DRUG LABEL
Packager	Publix Super Markets Inc
Generic Name
Product Class
Product Number
Application Number	PART352

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Active ingredients

Avobenzone 3.0%

Homosalate 13.0%

Octisalate 5.0%

Octocrylene 2.0%

Oxybenzone 4.0%
Purpose

Sunscreen
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures ( see Directions) decrease the risk of skin cancer and early skin aging caused by sun.
Warnings
For external use only
When using this product
- keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if

rash occurs

Keep out of the reach of children.

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

May stain some fabrics.
Directions
- apply literally 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 increase 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 am - 2 pm
- Wear long sleeves shirts, pants, hats and sunglasses
- children under 6 month of age: Ask a doctor
Other information

protect this product from excessive heat and direct sun
Inactive ingredients

Water, Styrene/Acrylates Copolymer, Sorbitol, Benzyl Alcohol, Triethanolamine, Dimethicone, Polyglyceryl-3 Distearate, Sorbitan Isostearate, Stearic Acid, VP/Eicosene Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.
Principal Display Panel

Publix

kids spray sunscreen

50 SPF

MOISTURIZING

VERY WATER RESISTANT

NON-IRRITATING

Broad Spectrum Protection

8 FL OZ(237 mL)

INGREDIENTS AND APPEARANCE

PUBLIX KIDS
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56062-706
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56062-706-16	226 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/14/2012

Labeler - Publix Super Markets Inc (006922009)

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Medic

PUBLIX KIDS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PUBLIX SUPER MARKETS INC]

When using this product

Stop use and ask a doctor if

Other information

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