Your browser does not support JavaScript! PUBLIX SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PUBLIX SUPER MARKETS INC]
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PUBLIX SPF 30 (avobenzone, homosalate, octisalate, octocrylene) lotion
[Publix Super Markets Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate    5.0%

Octocrylene 10.0%



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


Principal Display Panel

publix

SUNSCREEN

LOTION

BROAD SPECTRUM

SPF 30

MOISTURIZING

WATER RESISTlNT

(80 MINTUES)

UVA/UVB Protection

8 FL OZ (236 mL)

ZPU007A0.jpg

publix

SUNSCREEN

LOTION

BROAD SPECTRUM

SPF 30

MOISTURIZING

WATER RESISTlNT

(80 MINTUES)

UVA/UVB Protection

3 FL OZ (88 mL)

ZPU015A0.jpg
PUBLIX   SPF 30
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:56062-713
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE10 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ETHYLHEXYL PALMITATE 
SORBITOL 
DIETHYLHEXYL SYRINGYLIDENEMALONATE 
TROLAMINE 
GLYCERYL MONOSTEARATE 
EDETATE DISODIUM 
PEG-100 STEARATE 
TRICAPRYLIN 
OLETH-3 
TOCOPHEROL 
SODIUM ASCORBYL PHOSPHATE 
ALOE VERA LEAF 
BENZYL ALCOHOL 
CHLORPHENESIN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-713-16226 g in 1 BOTTLE, PLASTIC
2NDC:56062-713-2285 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/16/2013
Labeler - Publix Super Markets Inc (006922009)

Revised: 7/2013
 
Publix Super Markets Inc

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