Label: LC SKINCARE - ELLA SUNSCREEN BROAD SPECTRUM SPF 55- octinoxate and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 66163-2614-2 - Packager: Cosmetic Solutions LLC
- 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 September 30, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
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DIRECTIONS
Apply liberally and evenly 15 minutes before sun exposure. *Reapply: At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours.
- 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.
*For children under 6 months of age: Ask a doctor.
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INACTIVE INGREDIENTS
Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.
- OTHER INFORMATION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
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INGREDIENTS AND APPEARANCE
LC SKINCARE - ELLA SUNSCREEN BROAD SPECTRUM SPF 55
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66163-2614 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 48 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Isocetyl Stearate (UNII: 3RJ7186O9W) Sorbitol (UNII: 506T60A25R) Cetostearyl Alcohol (UNII: 2DMT128M1S) Cyclomethicone 5 (UNII: 0THT5PCI0R) Glyceryl Monostearate (UNII: 230OU9XXE4) PEG-100 Stearate (UNII: YD01N1999R) Alcohol (UNII: 3K9958V90M) Octisalate (UNII: 4X49Y0596W) Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3) Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) Ethylhexylglycerin (UNII: 147D247K3P) Betula Pubescens Bark (UNII: 3R504894L9) Garden Cress Sprout (UNII: PWQ18YNR62) Sage (UNII: 065C5D077J) Cola Acuminata Seed (UNII: 1F8VIW1479) Camellia Oleifera Leaf (UNII: 5077EL0C60) Aloe Vera Leaf (UNII: ZY81Z83H0X) Xanthan Gum (UNII: TTV12P4NEE) Isomalt (UNII: S870P55O2W) Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM) Triethoxycaprylylsilane (UNII: LDC331P08E) Sodium Benzoate (UNII: OJ245FE5EU) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66163-2614-2 50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2019 Labeler - Cosmetic Solutions LLC (807907928)
