Label: FACE SPF 50- avobenzone,octinoxate,octocrylene, oxybenzone, titanium dioxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 73310-5022-2 - 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)
- Drug Facts Active ingredients
- PURPOSE
- USES
- WARNINGS
-
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
- SUNSCREEN LABEL
-
INGREDIENTS AND APPEARANCE
FACE SPF 50
avobenzone,octinoxate,octocrylene, oxybenzone, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73310-5022 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 mg in 5 mL 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1 mg in 5 mL Inactive Ingredients Ingredient Name Strength PEG-100 STEARATE (UNII: YD01N1999R) 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:73310-5022-2 50 mL in 1 CONTAINER; 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(73310-5022)