FACE SPF 50- avobenzone,octinoxate,octocrylene, oxybenzone, titanium dioxide 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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SUNSCREEN Face SPF 50

Drug Facts
Active ingredients

AVOBENZONE 2%

OCTINOXATE 2%

OCTOCRYLENE 2%

OXYBENZONE 2%

TITANIUM DIOXIDE 2%

PURPOSE

SUNSCREEN

USES

helps prevent sunburn

use as directed with other sun protection measures (see Direction), decrease the risk of skin cancer and early skin aging caused by the sun

WARNINGS

For external use only

Do not use on damaged or broken skin

Stop use and ask doctor if rash occurs

When using this product, keep put of eyes. Rinse with water to remove

Keep out of reach of children. If swalloed, get medical help or contact Poison Control Center right away.

DIRECTIONS

apply liberally 15 minutes before sun exposure

reapply: at least every 2 hours, immediately after towel drying

use a water-resistant sunscreen if swimming or sweating

children under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:

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

wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS

ammonium acryloydimethytaurate-vp copolymer, bis-ethylhexyloxphenol methoxphenyl triazine, BHT, butyrospermum parkii butter extract, caprylic capric triglyceride, carbomer, carthamus, cetearyl alcohol, citronellol,coumarin, diethylhexylsyringylidenemalonate, decyl gluside, diisopropyl sebacate, dimethicone, dimethiconol behenate, c12-15 alkyl benzoate, glycerin, glyceryl stearate, hexyl cinnamal, hydrolyzed soy protein, hydrolyzed wheat protein, limanathes alba seed oil, limonene, linalool, methylene bisbenzotriazolyl tetramethybutyphenol (nano), menthyl lactate, methylisothiazolinone, olea europapea oil unasonifiables, parfum, peg-100 stearate, phenoxyethanol, pseudoalteromonas ferment extract, propylene glycol, tocopherylacetate, triethanolamine, tripeptide-1, tripeptide-10 citrulline, vp-eicosene copolymer, water, xanthan gum

OTHER INFORMATION

Protect this product from excessive heat and direct sun

SUNSCREEN LABEL

sunscreen 5022 spf 50.jpgSUNSCREEN FACE SPF 50 SPRAY 5022

FACE  SPF 50
avobenzone,octinoxate,octocrylene, oxybenzone, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73310-5022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 mg  in 5 mL
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
PEG-100 STEARATE (UNII: YD01N1999R) 1 mg  in 5 mL
Product Characteristics
Colorwhite (Cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73310-5022-250 mL in 1 CONTAINER; 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(73310-5022)

Revised: 9/2019
Document Id: 923435ed-eace-326f-e053-2a95a90abf81
Set id: 90d3e398-a820-1608-e053-2a95a90ab318
Version: 2
Effective Time: 20190910
 
AGEFARM SRL