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Publix

Publix Super Markets Inc

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Avobenzone 2.0%

Homosalate 10.0%

Octisalate    5.0%

Octocrylene 5.0%



Purpose

Sunscreen


Publix 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, Ethylhexyl Plamitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG_100 Stearate,Disodium EDTA, Oleth-3, Tocopherol,Aloe Barbadensis Leaf juice Powder,Benzyl Alcohol, Chlorphenesin, Fragrance.


Principal Display Panel

publix

Ssunscreen

LOTION

BROAD SPECTRUM

SPF 15

MOISTURIZING

WATER RESISTANT

(80 MINUTES)

UVA/UVB Protection

8 FL OZ (236mL)

Publix

Publix

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:56062-709
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 2 g
HOMOSALATE Homosalate 10 g
OCTISALATE OCTISALATE 5 g
OCTOCRYLENE Octocrylene 5 g

Inactive Ingredients

Ingredient Name Strength
water
ETHYLHEXYL PALMITATE
sorbitol
DIMETHICONE
TROLAMINE
GLYCERYL MONOSTEARATE
EDETATE DISODIUM
PEG-100 STEARATE
Tocopherol
Aloe Vera Leaf
BENZYL ALCOHOL
CHLORPHENESIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:56062-709-16 226 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-07-16


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