Label: ALL DAY MOISTURE WITH AHAS SPF 15 BROAD SPECTRUM SUNSCREEN- homosalate, octisalate, oxybenzone, avobenzone, octocrylene liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68634-055-01 - Packager: AMCOL Health & Beauty Solutions, Inc. DBA
- 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 March 8, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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.
- 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 of higher and other sun protection measures including:
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- limit time in the sun, especially from 10 a.m.-2 p.m.
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- wear long-sleeved shirts, pants, hats and sunglasses.
AM All Day Moisture with AHAs SPF 15 Broad Spectrum Sunscreen
- 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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Questions or Comments?
1-877-435-7383
Monday-Friday 8AM EST - 10PM EST
Saturday 10AM EST - 4PM EST
ND.LAB045 R1
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160308
AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care
301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com
lauren.haase@amcol.com - Principal Display Panel-Tube Label
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INGREDIENTS AND APPEARANCE
ALL DAY MOISTURE WITH AHAS SPF 15 BROAD SPECTRUM SUNSCREEN
homosalate, octisalate, oxybenzone, avobenzone, octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68634-055 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 100 g in 2 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 g in 2 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 40 g in 2 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20 g in 2 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 13 g in 2 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) glycolic acid (UNII: 0WT12SX38S) glycerin (UNII: PDC6A3C0OX) steareth-20 (UNII: L0Q8IK9E08) PEG-100 Stearate (UNII: YD01N1999R) hexyl laurate (UNII: 4CG9F9W01Q) dimethicone (UNII: 92RU3N3Y1O) cetyl alcohol (UNII: 936JST6JCN) Steareth-2 (UNII: V56DFE46J5) methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q) aluminum hydroxide (UNII: 5QB0T2IUN0) potassium cetyl phosphate (UNII: 03KCY6P7UT) camellia oleifera leaf (UNII: 5077EL0C60) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) Panthenol (UNII: WV9CM0O67Z) allantoin (UNII: 344S277G0Z) Butylene glycol (UNII: 3XUS85K0RA) bentonite (UNII: A3N5ZCN45C) glyceryl monostearate (UNII: 230OU9XXE4) Hydrogenated Palm glycerides (UNII: YCZ8EM144Q) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) xanthan gum (UNII: TTV12P4NEE) edetate disodium (UNII: 7FLD91C86K) phenoxyethanol (UNII: HIE492ZZ3T) ethylhexylglycerin (UNII: 147D247K3P) chlorphenesin (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68634-055-01 50 mL 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 01/01/2012 Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803) Establishment Name Address ID/FEI Business Operations AMCOL Health & Beauty Solutions, Inc. DBA 872684803 MANUFACTURE(68634-055) , ANALYSIS(68634-055)
