Label: EGF UV SHIELD- oxtinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58831-2001-1 - 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.
Drug Label Information
Updated December 22, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Drug Fact
Active ingredient
Octinoxate 7.50%
Octisalate 5.00%
Zinc Oxide 4.90%
Titanium Dioxide 4.15%
Amiloxate 2.00%Keep out of reach of children
Stop use and ask a doctor
if rash or irritation develops and lasts.Keep out of reach of children
if swallowed, get medical help or contact a Poison Control Center right away.Indication & usage
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 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-sleeve shirts, pants, hats, and sunglasses
-Children under 6 months: Ask a doctor
Warning
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. If sun irritation develops or increases.
When using this product keep out of eyes. Rinse with water to remove.
Inactive ingredient
Water, Propylene Glycol, Cyclopentasiloxane, Hydrogenated Poly(C6-14 Olefin Polymer), pentylent glycol, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Sesquioleate, butylene glycol, Aluminum Hydroxide, Stearic Acid, silica Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate Crosspolymer, caprylyl glycol, tocopheryl acetate, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, jojoba seed oil, ethyhexylglycerin, Aloe Barbadensis Leaf Juice, squalane, sorbitan isostearate, chamomilla recutita (matricaria) flower extract, macadamia ternifolia seed oil, rh-oligopeptide-1, chaenomeles sinensis fruit extract, cinnamomum cassia bark extract, diospyros kaki leaf extract, artemisia princeps leaf extract, sorbitol, camellia sinensis leaf extract, glycerin, chrysanthellum indicum extract, lecithin, glyceryl linoleate, glyceryl linolenate, phenoxyethano, xanthan gum, acetyl hexapeptide-8, sodium ascorbyl phosphate, retinyl palmitate, di-sodium edta, glyceryl caprylate, fragrance
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EGF UV SHIELD
oxtinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58831-2001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.9 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.15 g in 100 mL AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58831-2001-1 60 mL in 1 TUBE; Type 0: Not a Combination Product 07/07/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/07/2018 Labeler - Dermaesthetics Inc. (688384549) Registrant - Dermaesthetics Inc. (688384549) Establishment Name Address ID/FEI Business Operations Eyesome Co Ltd 557795360 manufacture(58831-2001) Establishment Name Address ID/FEI Business Operations Dermaesthetics Inc. 688384549 relabel(58831-2001)
