Label: EGF UV SHIELD- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58831-1001-1, 58831-1001-2 - 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.
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.
Dosage & administration
Uses
Helps prevent sunburn.
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.
Inactive ingredient
Water, Propylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hydrogenated Poly(C6-14 Olefin), Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Disteardimonium Hectorite, Magnesium Sulfate, Sorbitan Sesquioleate, Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Methyl Methacrylate Crosspolymer, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, Sorbitan Isostearate, Squalane, Simmondsia Chinensis(Jojoba) Seed Oil, Macadamia Ternifolia Seed Oil, Diospyros Kaki Leaf Extract, Cinnamomum Cassia Bark Extract, Artemisia Princeps Leaf Extract, Chrysanthellum Indicum Extract, Chaenomeles Sinensis Fruit Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Chamomilla Recutita(Matricaria) Flower Extract, Lecithin, Sorbitol, Xanthan Gum, Glyceryl Linoleate, Glyceryl Linolenate, rh-Oligopeptide-1, Acetyl Hexapeptide-8, Sodium Ascorbate, Retinyl Palmitate, Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben, Fragrance
- EGF UV Shield
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INGREDIENTS AND APPEARANCE
EGF UV SHIELD
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58831-1001 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 60 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 60 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.9 g in 60 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.15 g in 60 g AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE 2 g in 60 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BETAINE (UNII: 3SCV180C9W) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PURSLANE (UNII: M6S840WXG5) PONCIRUS TRIFOLIATA FRUIT (UNII: 44445L49J2) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SQUALANE (UNII: GW89575KF9) JOJOBA OIL (UNII: 724GKU717M) MACADAMIA OIL (UNII: 515610SU8C) DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO) CHINESE CINNAMON (UNII: WS4CQ062KM) ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G) CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0) CHAENOMELES SINENSIS FRUIT (UNII: 6S5Q1Q537Z) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMOMILE (UNII: FGL3685T2X) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L) GLYCERYL LINOLENATE (UNII: SGB6X4G86K) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) SODIUM ASCORBATE (UNII: S033EH8359) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) Product Characteristics Color white (silver) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58831-1001-2 1 in 1 BOX 12/01/2018 1 NDC:58831-1001-1 60 g 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 06/26/2013 Labeler - Dermaesthetics Inc. (688384549) Registrant - Dermaesthetics Inc. (688384549) Establishment Name Address ID/FEI Business Operations Eyesome Co Ltd 557795360 manufacture(58831-1001) Establishment Name Address ID/FEI Business Operations Dermaesthetics Inc. 688384549 relabel(58831-1001)