PUBLIX  SPF 30- avobenzone, homosalate, octisalate and octocrylene lotion 
Publix Super Markets Inc

Disclaimer: 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.

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Drug Facts

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate    5.0%

Octocrylene 10.0%



Purpose

Sunscreen


Uses

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


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:



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 Type HUMAN OTC DRUG Item Code (Source) NDC:56062-713
Route of Administration TOPICAL DEA Schedule     
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 10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SORBITOL (UNII: 506T60A25R)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TRICAPRYLIN (UNII: 6P92858988)  
OLETH-3 (UNII: BQZ26235UC)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:56062-713-16 226 g in 1 BOTTLE, PLASTIC
2 NDC:56062-713-22 85 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 07/16/2013
Labeler - Publix Super Markets Inc (006922009)

Revised: 7/2013
Document Id: afdac898-5b73-408b-8c82-71c8f63b5238
Set id: 20144a32-26c6-47ea-8958-7407f3d0b228
Version: 1
Effective Time: 20130716
 
Publix Super Markets Inc