Label: HYDRATING ANTIOXIDANT MOITURIZER- avobenzone, homosalate, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-0540-01 - Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
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 November 9, 2017
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WARNINGS AND PRECAUTIONS
- QUESTIONS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
•apply liberally 5 minutes before sun exposure
•reapply at least every 2 hours
•use water resistant sunscreen if swimming or
sweating.
•children under 6 months of age: ask a doctor.
•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, specially from 10 a.m. - 2 p.m.
•wear long-sleeved shirts, pants, hats and sunglasses.
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients Water, Dimethicone,
Trisiloxanane, Isononyl Isononanoate, Glycerin, Cetyl Alcohol,
Steareth-21, Nylon-12, Silica, Stearyl Alcohol, Glyceryl Stearate,
PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin,
Dimethicone Crosspolymer, Fragrance, Propylene Glycol,
Myrtus Communis Extract, Xanthan Gum, Retinyl Palmitate, Polysorbate 20, Carbomer,
Disodium EDTA, Ascorbic Acid, Sodium Hydroxide, ,BHT, Hyaluronic Acid.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRATING ANTIOXIDANT MOITURIZER
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0540 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.478 g in 118 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.72 g in 118 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.72 g in 118 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.36 in 118 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRISILOXANE (UNII: 9G1ZW13R0G) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) STEARETH-21 (UNII: 53J3F32P58) NYLON-12 (UNII: 446U8J075B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MYRTUS COMMUNIS LEAF (UNII: U20N87188F) XANTHAN GUM (UNII: TTV12P4NEE) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) POLYSORBATE 20 (UNII: 7T1F30V5YH) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) HYALURONIC ACID (UNII: S270N0TRQY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0540-01 118 mL in 1 PACKAGE; Type 0: Not a Combination Product 10/28/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/28/2017 Labeler - Walgreen Company (008965063)
