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
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 June 23, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
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INACTIVE INGREDIENTS
Aqua, Cyclopentasiloxane, Silica, 4-Methylbenzylidene Camphor, Cyclohexasiloxane, Cetyl Ethylhexanoate, Sorbitan Isostearate, Glycerin,
Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Calcium Stearate, Glyceryl Caprylate, Betaine, Beeswax, Allantoin, Ozokerite, Glyceryl Caprylate, Butylene Glycol, Aloe Barbadensis Leaf Juice Powder, Xanthan Gum, Triethoxycaprylylsilane, 1,2-Hexanediol, Sodium DNA, Ginkgo Biloba Leaf Extract, Ethylhexylglycerin, Lecithin, Polysorbate 20, sr-Rainbow Trout Oligopeptide-1 sh-Oligopeptide-1, sh-Oligopeptide-1. - PURPOSE
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WARNINGS
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
■ For external use only■ Do not use on damaged or broken skin.
■ When using this product keep out of eyes, rinse with water to remove.
■ Stop use and ask a doctor if rash or irritation develops.
■ Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away. -
DESCRIPTION
Uses:
■ 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.Directions:
■ Apply generously and evenly 15-20 minutes before sun exposure.
■ Use a water resistant sunscreen if swimming or sweating.
■ Reapply every 1-2 hours after towel drying, swimming, or perspiring.
■ 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 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.
- Children under 6 months: Consult a doctor. - Other Information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EGF FGF DNA UV SHIELD
ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate creamProduct 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) 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)
