FACE AND BODY SPF 15- octinoxate, oxybenzone, avobenzone cream 
AGEFARM SRL

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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AGESKIN Sunscreen SPF 15 Face and Body

ACTIVE INGREDIENTS

Octinoxate

Oxybenzone

Avobenzone

PURPOSE

Sunscreen

USES

Helps prevent sunburn

Use as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNING

For external use only.

Do not use on damaged or broken skin.

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 reach of children. If product swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply liberally, 15 minutes before sun exposure

Reapply: at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating

SUN PROTECTION MEASURES. Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease this risk,regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun,especially from 10 a.m.- 2 p.m.

Wear long-sleaved shirts, pants, hats, and sunglusses

Children under 6 months. Ask a doctor

INACTIVE INGREDIENTS

water, C12-15 alkyl benzoate, disopropyl sebacate, isononyl isononanoate, squalane, glyceril stearate, cocos nucifera oil, cetearyl alcohol, propylene glycol, peg-100 stearate, glycerin, dimethicone, vp/eicosene copolymer, calendula officinalis flower extract, ammonium acryloyldimethyltaurate, vp/copolymer, bixia orellana seed extract, hydrolyzed wheat protein, hydrolyzed soy protein, tocopherol, tocopheryl acetate, tripeptide-10 citrulline, caprylic/capric triglyceride, xanthan gum, pseudoalteromonas ferment extract, tripeptide-1, lecithin, carbomer, triethanolamine, benzyl alcohol, dimethiconol behenate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, diethylhexyl syringylidenemalonate, parfum, hexyl cinnamal, coumarin, limonene, linalool, citronellol, menthyl lactate, ethylhexylglycerin, polysorbate 60

STORAGE

Protect this container from heat and sun

SUNSCREEN LABEL

SCREEN 1510 SPF 15.jpgSCREEN 1510 SPF 15

FACE AND BODY  SPF 15
octinoxate, oxybenzone, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73310-1522
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1 mg  in 5 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 mg  in 5 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) 1 mg  in 5 mL
Product Characteristics
Colorwhite (Cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73310-1522-3150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/28/2019
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/28/2019
Labeler - AGEFARM SRL (439202467)
Establishment
NameAddressID/FEIBusiness Operations
COSMESIT Srl339071951manufacture(73310-1522)

Revised: 9/2019
Document Id: 9233ad9e-b408-5223-e053-2995a90ab22a
Set id: 90910cd1-e140-6803-e053-2a95a90a730b
Version: 2
Effective Time: 20190910
 
AGEFARM SRL