FACE AND BODY SPF 30- avobenzone,octinoxate,octocrylene,oxybenzone,titanium dioxide, zinc oxide 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 SPF 30

ACTIVE INGREDIENTS

AVOBENZONE

OCTINOXATE

OCTOCRYLENE

OXYBENZONE

ZINC OXIDE

TITANIUM DIOXIDE

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

WARNINGS

For external use only

Do not use damaged or broken skin

Stop use and ask doctor if rash occurs

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

Keep out of reach of children. If swallowed, 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 of skin cancer and early skin aging. To decrease this risk, regularly use 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-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS

ammonium acryloydimethyltaurate vp copolymer, bixa orellana seed extract, benzyl alcohol, bis-ethylhexyloxyphenol methoxyphenyl triazine, caprylic-capric triglyceride, cetaryl alcohol, citronellol, coumarin, c12-15 alkyl benzoate, decyl glucose, diisopropyl sebacate, dimethicone, dimethiconol behenate, ethylhexlglycerin, glycerin, glyceryl stearate, hexyl cinnamal, hydrolyzed soy protein, hydrolyzed wheat protein, limonene, linalool, menthylene bis-benzotriazoyl tetramethybutyphenol (nano), parfum, peg-100 stearate, propylene glycol, menthyl lactate, silica, tocopheryl acetate, tocopherol, tripeptide-1, vp-eicosene copolymer, water, xanthan gum

OTHER INFORMATION

Protect this product from excessive heat and direct sun

SUNSCREEN LABEL

SUNSCREEN 22 SPF 30.jpgSUNSCREEN 22 SPF 30.jpg

FACE AND BODY  SPF 30
avobenzone,octinoxate,octocrylene,oxybenzone,titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73310-3022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1 mg  in 5 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 mg  in 5 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1 mg  in 5 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 mg  in 5 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 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:73310-3022-3150 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(73310-3022)

Revised: 9/2019
Document Id: 92343192-a940-84f0-e053-2995a90a68af
Set id: 90d394e8-7b90-9f9f-e053-2995a90a9a82
Version: 2
Effective Time: 20190910
 
AGEFARM SRL