Label: EQUATE BEAUTY ROAD SPECTRUM SPF30- avobenzone, homosalate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-300-16 - Packager: Wal-Mart Stores, Inc
- 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 April 19, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- apply liberally 15 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 sking 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
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive Ingredients water, dimethicone, trisiloxane, isononyl isononanoate, glycerin,
cetyl alcohol, steareth-21, nylon-12, silica, stearyl alcohol, glyceryl stearate, PEG-100 stearate,
phenoxyethanol, ethylhexylglycerin, dimethicone crosspolymer, sodium styrene/acrylates/divinylbenzene
copolymer, ammonium nonoxynol-4 sulfate, fragrance, propylene glycol, myrtus communis extract,
xantan gum, retinyl palmitate, polysorbate 20, acrylates/C10-30 alkyl acrylate crosspolymer,
disodium EDTA, ascorbic acid, sodium hydroxide, BHT, hyaluronic acid
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EQUATE BEAUTY ROAD SPECTRUM SPF30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE .02 g in 29 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE .04 g in 29 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE .04 g in 29 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE .02 g in 29 g 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) STYRENE (UNII: 44LJ2U959V) SODIUM (UNII: 9NEZ333N27) DIVINYLBENZENE (UNII: IZ715T4SBU) AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MYRTUS COMMUNIS LEAF (UNII: U20N87188F) XANTHAN GUM (UNII: TTV12P4NEE) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALLYL ACRYLATE (UNII: 705GA5O3US) EDETATE DISODIUM (UNII: 7FLD91C86K) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) TRIS-BHT MESITYLENE (UNII: 51DM34B894) HYALURONIC ACID (UNII: S270N0TRQY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-300-16 1 in 1 CARTON 04/15/2016 1 29 g in 1 BOTTLE; 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 04/15/2016 Labeler - Wal-Mart Stores, Inc (051957769)