Label: FACE AND BODY SPF 15- octinoxate, oxybenzone, avobenzone cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 73310-1522-3 - Packager: AGEFARM SRL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 10, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNING
-
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
- SUNSCREEN LABEL
-
INGREDIENTS AND APPEARANCE
FACE AND BODY SPF 15
octinoxate, oxybenzone, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73310-1522 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1 mg in 5 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1 mg in 5 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1 mg in 5 mL Inactive Ingredients Ingredient Name Strength ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) 1 mg in 5 mL Product Characteristics Color white (Cream) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73310-1522-3 150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/28/2019 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/28/2019 Labeler - AGEFARM SRL (439202467) Establishment Name Address ID/FEI Business Operations COSMESIT Srl 339071951 manufacture(73310-1522)
SCREEN 1510 SPF 15