Label: EVEN UP SUNSCREEN SPF 50- titanium dioxide and zinc oxide liquid
- NDC Code(s): 68078-003-02, 68078-003-04
- Packager: Colorescience
- 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 October 5, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
- Reapply:
- After 40 minutes of swimming or sweating.
- Immediately after towel drying.
- At least every 2 hours.
- Children under 6 months: ask a doctor.
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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 10 a.m.– 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
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Inactive ingredients
Cyclopentasiloxane, Isocetyl Stearoyl Stearate, Dimethicone Crosspolymer, Thermus Thermophillus Ferment, Water/Aqua/Eau, Hydrated Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium Lauriminodipropionate Tocopheryl Phosphates, Panthenyl Triacetate, Acetyl Rheum Rhaponticum Root Extract, Bidens Pilosa Extract, Elaeis Guineensis (Palm) Oil, Gossypium Herbaceum (Cotton) Seed Oil, Linum Usitatissimum (Linseed) Seed Oil, Tocopherol, Dimethiconol, Citrus Paradisi (Grapefruit) Seed Extract, Glycerin, Dimethicone, Fusanus Spicatus Wood Oil, Vanilla Planifolia Fruit Extract, Ascorbic Acid, Caprylic/Capric Triglyceride, Pentylene Glycol, Triethoxycaprylylsilane, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Potassium Sorbate, Farnesol, Iron Oxides (CI 77491, CI 77492, CI 77499).
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
EVEN UP SUNSCREEN SPF 50
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 116 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 86 mg in 1 mL Inactive Ingredients Ingredient Name Strength Cyclomethicone 5 (UNII: 0THT5PCI0R) Isocetyl Stearoyl Stearate (UNII: IJV4LS383R) Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5) Thermus Thermophilus Lysate (UNII: 775R692494) Water (UNII: 059QF0KO0R) Panthenol Triacetate, (+)- (UNII: 1206E8961B) Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M) Glycerin (UNII: PDC6A3C0OX) Dimethicone (UNII: 92RU3N3Y1O) Palm Oil (UNII: 5QUO05548Z) Cottonseed Oil (UNII: H3E878020N) Citrus Paradisi Seed (UNII: 12F08874Y7) Triethoxycaprylylsilane (UNII: LDC331P08E) Linseed Oil (UNII: 84XB4DV00W) Santalum Spicatum Oil (UNII: H9LVS6REV4) Ascorbic Acid (UNII: PQ6CK8PD0R) Pentylene Glycol (UNII: 50C1307PZG) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Phenoxyethanol (UNII: HIE492ZZ3T) VANILLA BEAN (UNII: Q74T35078H) Potassium Sorbate (UNII: 1VPU26JZZ4) Benzoic Acid (UNII: 8SKN0B0MIM) Dehydroacetic Acid (UNII: 2KAG279R6R) Tocopherol (UNII: R0ZB2556P8) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) Hydrated Silica (UNII: Y6O7T4G8P9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68078-003-04 1 in 1 CARTON 10/05/2015 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68078-003-02 1 mL in 1 PACKET; Type 0: Not a Combination Product 10/05/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 10/05/2015 Labeler - Colorescience (128731929)
