Label: EGF FGF DNA UV SHIELD- ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate cream
- NDC Code(s): 58831-1100-1, 58831-1100-2
- Packager: Dermaesthetics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Updated October 5, 2021
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- ACTIVE INGREDIENTS
Aqua, Cyclopentasiloxane,Propylene Glycol, Silica, 4-Methylbenzylidene Camphor, Cyclohexasiloxane, Cetyl Ethylhexanoate, Sorbitan Isostearate, Glycerin, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Calcium Stearate, Dimethicone, Betaine, Beeswax, Allantoin, Ozokerite, Butylene Glycol, Aloe Barbadensis Leaf Juice Powder, Triethoxycaprylylsilane, Xanthan Gum, 1,2-Hexanediol, Sodium DNA, Ginkgo Biloba Leaf Extract, Ethylhexylglycerin, Lecithin, Polysorbate 20, sr-Rainbow Trout Oligopeptide-1 sh-Oligopeptide-1, sh-Oligopeptide-1
■ Helps prevent sun burn
■ If used as directed with other sun protection measures see Directions, decreases the risk of skin cancer and early skin aging caused by the sun.
For sunscreen use:
■ apply generously and evenly 15 minutes before sun exposure.
■ apply to all skin exposed to the sun.
■ children under 6 months of age: 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 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 10a.m-2p.m.
■ wear long sleeve shirts, pants, hats, and sunglasses.
■ reapply at least every 2 hours
■ use a water resistant sunscreen if swimming or sweating
- Other Information
- Questions or Comments?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EGF FGF DNA UV SHIELD
ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58831-1100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.24 g in 60 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 3.0 g in 60 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.04 g in 60 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Propylene Glycol (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58831-1100-2 1 in 1 CARTON 10/01/2021 1 NDC:58831-1100-1 60 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2021 Labeler - Dermaesthetics Inc. (688384549) Registrant - Dermaesthetics Inc. (688384549) Establishment Name Address ID/FEI Business Operations Aqualex 687515213 manufacture(58831-1100)