Label: JANE SEYMOUR NATURAL ADVANTAGE AM SPF 15 ALL DAY MOISTURE WITH AHAS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream
- NDC Code(s): 70605-026-11, 70605-026-13, 70605-026-57
- Packager: Guthy-Renker,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 February 2, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Use
- Helps prevents 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.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply 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:
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- Limit time in the sun, especially from 10 a.m.-2p.m.
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- Wear long-sleeved shirts, pants, hats and sunglasses.
- Other information
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Inactive ingredients
Water, Glycolic Acid, Glycerin, Steareth-20, PEG-100 Stearate, Hexyl Laurate, Dimethicone, Cetyl Alcohol, Steareth-2, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Ammonium Hydroxide, Potassium Cetyl Phosphate, Camellia Oleifera Leaf Extract, Tocopheryl Acetate, Ormenis Multicaulis Oil, Panthenol, Allantoin, Butylene Glycol, Bentonite, Glyceryl Stearate, Hydrogenated Palm Glycerides, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin, Chlorphenesin
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- PRINCIPAL DISPLAY PANEL - Tube Label
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INGREDIENTS AND APPEARANCE
JANE SEYMOUR NATURAL ADVANTAGE AM SPF 15 ALL DAY MOISTURE WITH AHAS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70605-026 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 2 mg in 100 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 10 mg in 100 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 5 mg in 100 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 1.3 mg in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 4 mg in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycolic Acid (UNII: 0WT12SX38S) Glycerin (UNII: PDC6A3C0OX) AMMONIA (UNII: 5138Q19F1X) Steareth-20 (UNII: L0Q8IK9E08) PEG-100 Stearate (UNII: YD01N1999R) Hexyl Laurate (UNII: 4CG9F9W01Q) Dimethicone (UNII: 92RU3N3Y1O) Steareth-2 (UNII: V56DFE46J5) Cetyl Alcohol (UNII: 936JST6JCN) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) Allantoin (UNII: 344S277G0Z) Panthenol (UNII: WV9CM0O67Z) Butylene Glycol (UNII: 3XUS85K0RA) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) Xanthan Gum (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) BENTONITE (UNII: A3N5ZCN45C) Phenoxyethanol (UNII: HIE492ZZ3T) Ethylhexylglycerin (UNII: 147D247K3P) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70605-026-13 50 mL in 1 TUBE; Type 0: Not a Combination Product 12/30/2017 2 NDC:70605-026-57 50 mL in 1 TUBE; Type 0: Not a Combination Product 12/30/2017 11/18/2020 3 NDC:70605-026-11 30 mL in 1 TUBE; Type 0: Not a Combination Product 12/30/2017 11/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/30/2017 Labeler - Guthy-Renker,LLC (948861877) Establishment Name Address ID/FEI Business Operations AMCOL HEALTH AND BEAUTY SOLUTIONS INC 872684803 MANUFACTURE(70605-026)