Label: FACE AND BODY SPF 30- avobenzone,octinoxate,octocrylene,oxybenzone,titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73310-3022-3 - 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.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
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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
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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
- SUNSCREEN LABEL
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INGREDIENTS AND APPEARANCE
FACE AND BODY SPF 30
avobenzone,octinoxate,octocrylene,oxybenzone,titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73310-3022 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1 mg in 5 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 mg in 5 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1 mg in 5 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1 mg in 5 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 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:73310-3022-3 150 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(73310-3022)
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