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

Publix by

Drug Labeling and Warnings

Publix by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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	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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Publix Super Markets Inc (006922009)